| 2026-07-01 |
Class II
|
Ongoing |
Z-2833-2026 |
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. |
— |
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| 2026-07-01 |
Class II
|
Ongoing |
Z-2832-2026 |
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. |
— |
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| 2026-07-01 |
Class II
|
Ongoing |
Z-2831-2026 |
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. |
— |
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| 2026-07-01 |
Class II
|
Ongoing |
Z-2830-2026 |
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. |
— |
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| 2026-07-01 |
Class II
|
Ongoing |
Z-2829-2026 |
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. |
— |
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| 2026-07-01 |
Class II
|
Ongoing |
Z-2828-2026 |
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. |
— |
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| 2026-07-01 |
Class II
|
Ongoing |
Z-2827-2026 |
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. |
— |
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. |
| 2026-05-06 |
Class II
|
Ongoing |
Z-2282-2026 |
Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System |
— |
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing… |
| 2026-04-09 |
Class II
|
Ongoing |
Z-2166-2026 |
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to… |
— |
Due to nonconforming products being inadvertently distributed. |
| 2026-01-21 |
Class II
|
Ongoing |
Z-1427-2026 |
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 008500… |
— |
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tiss… |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0601-2026 |
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shep… |
— |
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction… |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0600-2026 |
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illuminat… |
— |
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction… |
| 2025-10-31 |
Class II
|
Ongoing |
Z-0599-2026 |
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP … |
— |
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction… |
| 2025-07-02 |
Class II
|
Ongoing |
Z-2277-2025 |
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3… |
— |
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss great… |
| 2025-06-18 |
Class II
|
Ongoing |
Z-2171-2025 |
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip |
— |
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. |
| 2025-06-18 |
Class II
|
Ongoing |
Z-2170-2025 |
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip |
— |
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. |
| 2025-05-28 |
Class II
|
Ongoing |
Z-1914-2025 |
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. |
— |
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. |
| 2025-05-22 |
Class II
|
Ongoing |
Z-1940-2025 |
Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. |
— |
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled… |
| 2025-05-22 |
Class II
|
Ongoing |
Z-1939-2025 |
Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. |
— |
Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled… |
| 2025-03-28 |
Class II
|
Ongoing |
Z-1621-2025 |
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; |
— |
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. |
| 2025-03-28 |
Class II
|
Ongoing |
Z-1620-2025 |
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; |
— |
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1482-2025 |
Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1481-2025 |
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Nu… |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1480-2025 |
Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Nu… |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1479-2025 |
Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number… |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1478-2025 |
Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number… |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1477-2025 |
Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS) |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1476-2025 |
Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1475-2025 |
Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1474-2025 |
Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1473-2025 |
Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1472-2025 |
Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1471-2025 |
Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1470-2025 |
Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1469-2025 |
Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL |
— |
There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this ev… |
| 2025-01-29 |
Class II
|
Ongoing |
Z-1328-2025 |
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197 |
— |
Increase in complaints concerning "pullwire" breakage that may result in the broken pullwire remaining in the anchor implant body after deployment. |
| 2025-01-08 |
Class II
|
Ongoing |
Z-1139-2025 |
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades |
— |
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. |
| 2025-01-08 |
Class II
|
Ongoing |
Z-1138-2025 |
stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades |
— |
Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. |
| 2024-12-03 |
Class II
|
Ongoing |
Z-0807-2025 |
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-00… |
— |
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0370-2025 |
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgi… |
— |
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentiona… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0369-2025 |
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgica… |
— |
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentiona… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0368-2025 |
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosu… |
— |
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentiona… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0367-2025 |
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a… |
— |
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentiona… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0366-2025 |
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosur… |
— |
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentiona… |
| 2024-10-04 |
Class II
|
Ongoing |
Z-0365-2025 |
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appli… |
— |
There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentiona… |
| 2024-09-05 |
Class II
|
Ongoing |
Z-0063-2025 |
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of b… |
— |
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is con… |
| 2024-07-24 |
Class II
|
Completed |
Z-2731-2024 |
Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming,… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2730-2024 |
Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, d… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2729-2024 |
Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2728-2024 |
Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2727-2024 |
Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming,… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2726-2024 |
Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorti… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2725-2024 |
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decort… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2724-2024 |
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorti… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2723-2024 |
Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decor… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-07-24 |
Class II
|
Completed |
Z-2722-2024 |
Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the following manner: drilling, reaming, decor… |
— |
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2261-2024 |
This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contain… |
— |
Expired Products distributed to customers |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2260-2024 |
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the … |
— |
Expired Products distributed to customers |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2259-2024 |
The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available… |
— |
Expired Products distributed to customers |
| 2024-05-09 |
Class II
|
Ongoing |
Z-2219-2024 |
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System. |
— |
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. |
| 2023-12-06 |
Class II
|
Ongoing |
Z-1085-2024 |
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm |
— |
The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
| 2023-12-06 |
Class II
|
Ongoing |
Z-1084-2024 |
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm |
— |
The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
| 2023-09-13 |
Class II
|
Ongoing |
Z-0287-2024 |
Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, a… |
— |
Expired product distributed |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0257-2024 |
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0256-2024 |
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0255-2024 |
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0254-2024 |
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0253-2024 |
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0252-2024 |
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0251-2024 |
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0250-2024 |
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0249-2024 |
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0248-2024 |
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0247-2024 |
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0246-2024 |
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0245-2024 |
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0244-2024 |
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0243-2024 |
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0242-2024 |
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005 |
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An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0241-2024 |
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005 |
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An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0240-2024 |
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015 |
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An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-09-11 |
Class II
|
Ongoing |
Z-0239-2024 |
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005 |
— |
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label r… |
| 2023-08-23 |
Class II
|
Ongoing |
Z-2645-2023 |
Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 |
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Expired Product distributed |
| 2023-08-07 |
Class II
|
Ongoing |
Z-2602-2023 |
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Med. Press- Allows … |
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Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti… |
| 2023-08-07 |
Class II
|
Ongoing |
Z-2601-2023 |
Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the us… |
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Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti… |
| 2023-08-07 |
Class II
|
Ongoing |
Z-2600-2023 |
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to m… |
— |
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti… |
| 2023-08-07 |
Class II
|
Ongoing |
Z-2599-2023 |
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix b… |
— |
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti… |
| 2023-08-07 |
Class II
|
Ongoing |
Z-2598-2023 |
Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement with… |
— |
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti… |
| 2023-08-07 |
Class II
|
Ongoing |
Z-2597-2023 |
Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bon… |
— |
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti… |
| 2023-08-07 |
Class II
|
Ongoing |
Z-2596-2023 |
Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a cons… |
— |
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potenti… |
| 2023-07-10 |
Class II
|
Ongoing |
Z-2463-2023 |
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, di… |
— |
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type |
| 2023-06-28 |
Class II
|
Ongoing |
Z-0982-2025 |
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery |
— |
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains … |
| 2023-06-28 |
Class II
|
Ongoing |
Z-0981-2025 |
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery |
— |
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains … |
| 2023-06-28 |
Class II
|
Ongoing |
Z-0980-2025 |
The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neuro… |
— |
There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains … |
| 2023-03-02 |
Class II
|
Ongoing |
Z-1474-2023 |
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200 |
— |
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being conv… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1344-2023 |
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS … |
— |
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1343-2023 |
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135… |
— |
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1342-2023 |
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS … |
— |
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1341-2023 |
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS … |
— |
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1340-2023 |
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS … |
— |
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu… |
| 2023-03-01 |
Class II
|
Ongoing |
Z-1339-2023 |
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS … |
— |
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cu… |
| 2023-02-07 |
Class II
|
Ongoing |
Z-1191-2023 |
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bon… |
— |
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of… |
| 2023-01-25 |
Class II
|
Ongoing |
Z-1186-2023 |
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss. |
— |
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and coul… |
| 2023-01-25 |
Class II
|
Ongoing |
Z-1185-2023 |
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunc… |
— |
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and coul… |
| 2023-01-25 |
Class II
|
Ongoing |
Z-1184-2023 |
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunc… |
— |
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and coul… |
| 2022-03-28 |
Class II
|
Ongoing |
Z-1011-2022 |
Smart Toe II Intramedullary Arthrodesis Implant |
— |
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel … |
| 2022-01-14 |
Class II
|
Ongoing |
Z-0728-2022 |
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscop… |
— |
A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms… |
| 2021-05-27 |
Class II
|
Ongoing |
Z-2171-2021 |
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S |
— |
The devices have a different inner diameter than the diameter specified on the outer box label. |
| 2021-05-27 |
Class II
|
Ongoing |
Z-2170-2021 |
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S |
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The devices have a different inner diameter than the diameter specified on the outer box label. |
| 2021-02-26 |
Class II
|
Terminated |
Z-1428-2021 |
Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 … |
— |
Their is a potential that Video Processor/Illuminators may exhibit flickering, loss of image or unintended reboots. |
| 2020-09-25 |
Class II
|
Ongoing |
Z-0457-2021 |
Osteosynthesis Compression Staple EasyClip |
— |
The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more … |
| 2020-05-07 |
Class II
|
Terminated |
Z-2387-2020 |
Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices int… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2386-2020 |
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2385-2020 |
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2384-2020 |
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2383-2020 |
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants a… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2382-2020 |
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2381-2020 |
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants a… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2380-2020 |
Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants a… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2379-2020 |
Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2378-2020 |
Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single u… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2377-2020 |
Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single … |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2376-2020 |
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2375-2020 |
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices in… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2374-2020 |
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single us… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-05-07 |
Class II
|
Terminated |
Z-2373-2020 |
Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are singl… |
— |
Seal integrity of the blister pack may be compromised and sterility cannot be assured |
| 2020-01-07 |
Class II
|
Ongoing |
Z-1926-2020 |
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326 |
— |
Sterile drapes packaged in an unsealed pouch. |
| 2020-01-07 |
Class II
|
Ongoing |
Z-1925-2020 |
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH900… |
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Sterile drapes packaged in an unsealed pouch. |