Princeton, NJ, US · 11 510(k) clearances · 130 PMAs · 72 recalls (2 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | Unclassified | Unknown | 6 | 2025-10-08 |
| GWG | Endoscope, Neurological | Class II | Neurology | 1 | 2025-04-09 |
| KGN | Wound Dressing With Animal-Derived Material(S) | Unclassified | Unknown | 1 | 2021-10-08 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | 1 | 2021-07-27 |
| HBA | Neurosurgical Paddie | Class II | Neurology | 1 | 2020-11-20 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | 1 | 2020-06-29 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-09-18 | P900033-S117 | INTEGRA ® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Rege | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2026-09-18 | P850010-S119 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent- Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2026-09-18 | P840062-S099 | CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2026-09-18 | P810006-S115 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Fo | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2026-06-04 | P850010-S118 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent - Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2026-06-04 | P840062-S098 | CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2026-06-04 | P810006-S114 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Fo | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2026-05-27 | P850010-S117 | Helistat® Absorbable Collagen Hemostatic Agent | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2026-05-27 | P840062-S097 | CollaCote® and CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2026-05-27 | P810006-S113 | Collastat Absorbable Collagen Hemostatic Sponge | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2026-02-27 | P080013-S030 | DuraSeal Exact Spine Sealant System | Real-Time Process | NQR | Sealant, Dural | Unknown |
| 2026-02-27 | P040034-S041 | DuraSeal Dural Sealant System | Real-Time Process | NQR | Sealant, Dural | Unknown |
| 2026-02-25 | P900033-S116 | INTEGRA ® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template; Integra® Omnigraft Dermal Regenera | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2025-12-17 | P080013-S029 | DuraSeal Exact Spine Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2025-12-17 | P040034-S040 | DuraSeal Dural Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2025-09-09 | P900033-S115 | INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2025-02-24 | P900033-S114 | INTEGRA DERMAL REGENERATION TEMPLATE | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2025-02-18 | P900033-S113 | INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regenera | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2025-02-18 | P850010-S115 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2025-02-18 | P840062-S095 | CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2025-02-18 | P810006-S111 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2025-01-14 | P850010-S114 | Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2025-01-14 | P840062-S094 | CollaTape® Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2024-10-30 | P080013-S028 | DuraSeal Exact Spine Sealant System | Real-Time Process | NQR | Sealant, Dural | Unknown |
| 2024-10-30 | P040034-S039 | DuraSeal Dural Sealant System | Real-Time Process | NQR | Sealant, Dural | Unknown |
| 2024-08-29 | P850010-S113 | Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent - Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-08-29 | P840062-S093 | CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2024-08-29 | P810006-S110 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-08-22 | P850010-S112 | Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-08-22 | P810006-S109 | Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-07-24 | P850010-S111 | Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent-Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-07-24 | P840062-S092 | CollaCote®, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2024-07-24 | P810006-S108 | Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-06-03 | P900033-S112 | Integra® Dermal Regeneration Template | Real-Time Process | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2024-05-22 | P850010-S110 | Helistat/ Helitene Absorbable Collagen Hemostatic Agent | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-05-22 | P810006-S107 | Collastat/INSTAT Absorbable Collagen Hemostatic Agent | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-02-21 | P850010-S109 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-02-21 | P840062-S091 | CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2024-02-21 | P810006-S106 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2024-02-20 | P900033-S111 | INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2023-10-26 | P900033-S110 | Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2023-09-07 | P900033-S109 | Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2023-09-05 | P080013-S027 | DuraSeal Exact Spine Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2023-09-05 | P040034-S038 | DuraSeal Dural Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2023-08-21 | P900033-S108 | Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2023-06-07 | P900033-S107 | Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template Sterilized | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2023-05-24 | P080013-S026 | DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL) | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2023-05-24 | P040034-S037 | DuraSeal Dural Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2023-05-11 | P850010-S107 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2023-05-11 | P840062-S089 | CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2023-05-11 | P810006-S104 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2023-05-10 | P850010-S108 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2023-05-10 | P840062-S090 | CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2023-05-10 | P810006-S105 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2023-04-18 | P900033-S106 | INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2023-04-18 | P850010-S106 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2023-04-18 | P840062-S088 | CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2023-04-18 | P810006-S103 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2023-02-23 | P900033-S105 | Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2023-02-23 | P850010-S105 | Helistat/Helitene Absorbable Collagen Hemostatic Agent | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2023-02-23 | P840062-S087 | CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2023-02-23 | P810006-S102 | Collastat/INSTAT Absorbable Collagen Hemostatic Agent | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2023-02-16 | P080013-S025 | DuraSeal Exact Spinal Sealant | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2023-02-16 | P040034-S036 | DuraSeal Dural Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2023-02-07 | P900033-S104 | Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2023-01-25 | P080013-S022 | DuraSeal Exact Spine Sealant System | Normal 180 Day Track | NQR | Sealant, Dural | Unknown |
| 2023-01-25 | P040034-S033 | DuraSeal Dural Sealant System | Normal 180 Day Track | NQR | Sealant, Dural | Unknown |
| 2022-12-19 | P850010-S104 | Helistat® and Helitene® Absorbable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2022-12-19 | P810006-S101 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Fo | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2022-12-07 | P900033-S103 | INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2022-10-07 | P080013-S024 | DuraSeal Exact Spine Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2022-10-07 | P040034-S035 | DuraSeal Dural Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2022-07-06 | P900033-S101 | Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2022-07-06 | P850010-S103 | Helistat® and Helitene® Absorbable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2022-07-06 | P840062-S086 | CollaCote, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2022-07-06 | P810006-S100 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2022-07-01 | P900033-S102 | INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2022-05-20 | P900033-S100 | Integra® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2022-05-20 | P850010-S102 | Helistat® and Helitene® Absorbable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2022-05-20 | P840062-S085 | CollaCote, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2022-05-20 | P810006-S099 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2022-05-17 | P900033-S098 | Integra® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template and Integra® Omnigraft Dermal Regene | 135 Review Track For 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2022-05-05 | P900033-S099 | INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2022-04-28 | P850010-S101 | Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2022-04-28 | P840062-S084 | CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2022-04-28 | P810006-S098 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2022-04-20 | P850010-S100 | Helistat and Helitene Absoibable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-11-17 | P080013-S023 | DuraSeal Exact Spinal Sealant System. | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2021-11-17 | P040034-S034 | DuraSeal Dural Sealant System. | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2021-11-13 | P900033-S095 | INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat | Real-Time Process | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2021-11-13 | P850010-S098 | Helistat and Helitene Absorbable Collagen Hemostatic Agents | Real-Time Process | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-11-13 | P840062-S082 | CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery | Real-Time Process | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2021-11-13 | P810006-S096 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form | Real-Time Process | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-10-07 | P850010-S097 | Helistat and Helitene Absorbable Collagen Hemostatic Agents | 135 Review Track For 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-10-07 | P840062-S081 | CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery | 135 Review Track For 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2021-09-07 | P900033-S094 | INTEGRA Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template | 135 Review Track For 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2021-09-07 | P850010-S095 | Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen Hemostatic Agent Fibrillar Form | 135 Review Track For 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-09-07 | P840062-S080 | CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery | 135 Review Track For 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2021-09-07 | P810006-S095 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form | 135 Review Track For 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-08-12 | P900033-S097 | Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2021-08-12 | P850010-S099 | Helistat and Helitene Absorbable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-08-12 | P840062-S083 | CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2021-08-12 | P810006-S097 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-07-09 | P900033-S096 | Integra Dermal Regeneration Template and Intergra Meshed Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2021-04-28 | P850010-S096 | Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-02-26 | P900033-S093 | Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2021-02-26 | P850010-S094 | Helistat and Helitene Absorbable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-02-26 | P840062-S079 | CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2021-02-26 | P810006-S094 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-02-04 | P850010-S093 | Helistat® and Helitene® Absorbable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-02-04 | P810006-S093 | Collastat Absorbable Collagen Hemostatic Sponge and Collaslat Absorbable Collagen Hemostatic - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-01-19 | P900033-S092 | INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2021-01-19 | P850010-S092 | Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen hemostatic Agent - Fibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2021-01-19 | P840062-S078 | CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressing for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2021-01-19 | P810006-S092 | Collastat Absorbable Collagen Hemostatic Sponge and Collasta Absorbable Collagen hemostatic Agent - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2020-11-18 | P900033-S091 | Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2020-11-18 | P850010-S091 | Helistat and Helitene Absorbable Collagen Hemostatic Agents | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2020-11-18 | P840062-S077 | CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery | 30-Day Notice | LPG | Material, Dressing, Surgical, Polylactic Acid | Unknown |
| 2020-11-18 | P810006-S091 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2020-10-13 | P900033-S090 | Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regenera | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2020-09-16 | P080013-S021 | DuraSeal Exact Spine Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2020-09-16 | P040034-S032 | DuraSeal Dural Sealant System | 30-Day Notice | NQR | Sealant, Dural | Unknown |
| 2020-09-04 | P900033-S089 | Integra Dermal Regeneration Template | 30-Day Notice | MGR | Dressing, Wound And Burn, Interactive | Unknown |
| 2020-09-04 | P850010-S090 | Helistat Absorbable Collagen Hemostatic Sponge | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2020-09-04 | P810006-S090 | Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostat Agent - Microfibrillar Form | 30-Day Notice | LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery |
| 2020-08-17 | P080013-S019 | DuraSeal Exact Spine Sealant System | Real-Time Process | NQR | Sealant, Dural | Unknown |
| 2020-08-17 | P040034-S031 | DuraSeal Dural Sealant System | Real-Time Process | NQR | Sealant, Dural | Unknown |
| 2020-07-22 | P080013-S020 | DuraSeal Exact Spine Sealant System | Special (Immediate Track) | NQR | Sealant, Dural | Unknown |
| 2020-04-08 | P080013-S018 | DuraSeal Exact System | Normal 180 Day Track No User Fee | NQR | Sealant, Dural | Unknown |
| 2020-04-08 | P040034-S030 | DuraSeal Dural Sealant System | Normal 180 Day Track No User Fee | NQR | Sealant, Dural | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-02-06 | Class II | Ongoing | Z-1295-2025 | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Produ… | — | Possibility for the obturator to break (separate). |
| 2025-01-10 | Class II | Ongoing | Z-1168-2025 | Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Ve… | — | Potential that the induction seal is not completely sealed to the device tube packaging. |
| 2024-12-16 | Class II | Ongoing | Z-0979-2025 | CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides … | — | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. |
| 2024-12-16 | Class II | Ongoing | Z-0978-2025 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provid… | — | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. |
| 2024-12-16 | Class II | Ongoing | Z-0977-2025 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides … | — | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. |
| 2024-09-26 | Class II | Ongoing | Z-0262-2025 | Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 | — | Out of specification endotoxin levels. |
| 2024-09-20 | Class II | Ongoing | Z-0256-2025 | SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in pr… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0255-2025 | SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in prote… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0254-2025 | SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in prote… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0253-2025 | SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in … | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0252-2025 | SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in p… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0251-2025 | SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in pro… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0250-2025 | SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in pr… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0249-2025 | SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in pr… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0248-2025 | SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in pro… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0247-2025 | SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in … | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0246-2025 | SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in p… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0245-2025 | SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use i… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0244-2025 | SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use i… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0243-2025 | SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the u… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0242-2025 | SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in … | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0241-2025 | SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use i… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0240-2025 | SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0239-2025 | SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0238-2025 | SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0237-2025 | SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use i… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0236-2025 | SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the us… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-20 | Class II | Ongoing | Z-0235-2025 | MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of CO… | — | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codman Surgical Patties and Strips that may have resulted in out-of-… |
| 2024-09-13 | Class II | Ongoing | Z-0054-2025 | MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) … | — | There is a potential for pinholes in the applicator pouch film which creates a sterility concern. |
| 2024-07-09 | Class II | Ongoing | Z-2507-2024 | TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use wi… | — | Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepa… |
| 2024-06-07 | Class II | Ongoing | Z-2331-2024 | AURORA Surgiscope System. Sterile, single use device that contains a Sheath, Obturator, and Imager. | — | Potential sheath damage that could lead to tissue damage and/or track hemorrhage. |
| 2024-05-29 | Class II | Ongoing | Z-2167-2024 | CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification a… | — | Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment |
| 2024-05-07 | Class II | Ongoing | Z-2138-2024 | CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain… | — | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. |
| 2024-05-07 | Class II | Ongoing | Z-2137-2024 | CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be use… | — | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility. |
| 2024-05-07 | Class II | Ongoing | Z-2136-2024 | CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with di… | — | Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal that may compromise the product sterility. |
| 2024-04-17 | Class II | Ongoing | Z-1873-2024 | Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Nu… | — | Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device. |
| 2024-01-19 | Class II | Ongoing | Z-1203-2024 | Ref No: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the b… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1202-2024 | Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid s… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1201-2024 | Ref No: INSHITH / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1200-2024 | INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain. | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1199-2024 | Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1198-2024 | Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1197-2024 | Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brai… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1196-2024 | Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid spac… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1195-2024 | Ref No: HITHSP06 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1194-2024 | Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the bra… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2024-01-19 | Class II | Ongoing | Z-1193-2024 | Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ven… | — | A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility… |
| 2023-10-19 | Class II | Ongoing | Z-0499-2024 | Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the br… | — | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of t… |
| 2023-10-19 | Class II | Ongoing | Z-0498-2024 | Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:… | — | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of t… |
| 2023-10-19 | Class II | Ongoing | Z-0497-2024 | Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number… | — | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of t… |
| 2023-10-19 | Class II | Ongoing | Z-0496-2024 | Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number… | — | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of t… |
| 2023-10-19 | Class II | Ongoing | Z-0495-2024 | Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number:… | — | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of t… |
| 2023-10-19 | Class II | Ongoing | Z-0494-2024 | Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number… | — | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of t… |
| 2023-10-19 | Class II | Ongoing | Z-0493-2024 | Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe… | — | Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of t… |
| 2023-10-19 | Class II | Ongoing | Z-0492-2024 | Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Numbe… | — | Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of th… |
| 2023-10-19 | Class II | Ongoing | Z-0491-2024 | Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ve… | — | Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of th… |
| 2023-10-05 | Class I | Ongoing | Z-0548-2024 | CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP… | — | Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective a… |
| 2023-04-11 | Class II | Ongoing | Z-1614-2023 | Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monit… | — | Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity… |
| 2022-12-02 | Class II | Ongoing | Z-0909-2023 | Codman Surgical Patties, Part number 801400; SURG PATXRAY 1/2X1/2-200; Lot 6396457 | — | Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patt… |
| 2022-06-22 | Class I | Ongoing | Z-1395-2022 | CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor. | — | Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable fa… |
| 2022-02-28 | Class II | Ongoing | Z-0906-2022 | Integra Universal Flexible Arm part number REF 1362275 | — | Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition. |
| 2022-01-21 | Class II | Terminated | Z-0818-2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) moni… | — | Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, i… |
| 2022-01-21 | Class II | Terminated | Z-0817-2022 | Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) moni… | — | Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, i… |
| 2021-06-01 | Class II | Terminated | Z-2224-2021 | CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Numb… | — | Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier |
| 2021-03-17 | Class II | Terminated | Z-1354-2021 | CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking.… | — | Incorrect labeling, Catheter did not have the required holes and markings |
| 2020-12-14 | Class II | Terminated | Z-0725-2021 | Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use in the treatment of hydrocephalus when shu… | — | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. v… |
| 2020-12-14 | Class II | Terminated | Z-0724-2021 | Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a c… | — | Mislabeled product-Bactiseal Ventricular Catheter with Bactiseal Shunt System(823073) mislabeled as Bactiseal Endoscopic Ventricular Catheter (823087) and vs. v… |
| 2020-11-11 | Class II | Terminated | Z-0548-2021 | Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosur… | — | Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram |
| 2020-08-04 | Class II | Terminated | Z-2955-2020 | Integra Padgett Electric Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in pl… | — | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. |
| 2020-08-04 | Class II | Terminated | Z-2954-2020 | Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic sur… | — | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. |
| 2020-08-04 | Class II | Terminated | Z-2953-2020 | 13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: ar… | — | lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization. |
| 2020-02-07 | Class III | Terminated | Z-1470-2020 | NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for… | — | Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-08 | K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | LFL | Unclassified | Unknown |
| 2025-04-09 | K250752 | AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) | GWG | Class II | Neurology |
| 2024-07-11 | K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | LFL | Unclassified | Unknown |
| 2023-07-11 | K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Unclassified | Unknown |
| 2022-08-22 | K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Unclassified | Unknown |
| 2022-07-15 | K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Unclassified | Unknown |
| 2021-10-08 | K210128 | INTEGRA Wound Matrix (Macro-Channels) | KGN | Unclassified | Unknown |
| 2021-07-27 | K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | HRS | Class II | Orthopedic |
| 2020-11-20 | K193346 | Codman Surgical Patties & Strips | HBA | Class II | Neurology |
| 2020-06-29 | K201507 | Cadence Total Ankle System | HSN | Class II | Orthopedic |
| 2020-06-23 | K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | LFL | Unclassified | Unknown |