Warsaw, IN, US · 10 510(k) clearances · 58 PMAs · 35 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 2 | 2026-09-04 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | 2 | 2026-05-22 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 2 | 2022-01-06 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2023-08-22 |
| PHX | Shoulder Prosthesis, Reverse Configuration | Class II | Orthopedic | 1 | 2021-02-19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 1 | 2020-10-21 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | 1 | 2020-02-04 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-09-04 | P070026-S129 | CERAMAX CERAMIC HIP SYSTEM | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2026-08-27 | P070026-S130 | CERAMAX Ceramic Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2026-07-24 | P070026-S128 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2026-06-03 | P070026-S127 | CERAMAX CERAMIC HIP SYSTEM | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2026-04-29 | P070026-S125 | Ceramax® Ceramic Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2026-04-10 | P070026-S124 | Ceramax Ceramic Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2026-01-08 | P070026-S118 | Ceramax® Ceramic Total Hip System | 135 Review Track For 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2025-12-09 | P070026-S123 | Ceramax Ceramic Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2025-08-05 | P070026-S121 | CERAMAX CERAMIC HIP SYSTEM | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2025-08-01 | P070026-S122 | CERAMAX CERAMIC HIP SYSTEM | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2025-06-24 | P070026-S120 | CERAMAX® ceramic total hip system | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2025-04-04 | P070026-S119 | CERAMAX CERAMIC HIP SYSTEM | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2025-03-19 | P070026-S114 | DePuy Ceramax Ceramic Total Hip System | Normal 180 Day Track No User Fee | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2025-02-21 | P070026-S117 | Ceramax Ceramic Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2025-02-11 | P070026-S116 | Ceramax® Ceramic Total Hip System | Normal 180 Day Track No User Fee | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2024-11-08 | P070026-S115 | CERAMAX Ceramic Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2024-10-23 | P070026-S113 | CERAMAX Ceramic Total Hip System | Real-Time Process | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2024-08-06 | P070026-S112 | CERAMAX® Ceramic Total Hip System | Special (Immediate Track) | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2024-01-29 | P070026-S111 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2023-12-19 | P070026-S109 | Cermax® Ceramic Total Hip System | Normal 180 Day Track No User Fee | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2023-10-05 | P070026-S110 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2023-08-11 | P070026-S107 | CERAMAX Ceramic Total Hip System | Real-Time Process | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2023-06-22 | P070026-S108 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2023-05-19 | P070026-S106 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2023-05-02 | P070026-S105 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2023-02-09 | P070026-S104 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-12-08 | P070026-S103 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-10-04 | P070026-S102 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-08-26 | P070026-S101 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-08-10 | P070026-S086 | CERAMAX® Ceramic Total Hip System | Normal 180 Day Track No User Fee | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-07-25 | P070026-S095 | CERAMAX Ceramic Total Hip System | 135 Review Track For 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-07-12 | P070026-S100 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-06-07 | P070026-S098 | Ceramax Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-05-05 | P070026-S097 | CERAMAX® Ceramic Total Hip System | Special (Immediate Track) | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-04-14 | P070026-S096 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-03-22 | P070026-S094 | Ceramax® Ceramic Total Hip System | Special (Immediate Track) | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-03-10 | P070026-S093 | CERAMAX Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-03-05 | P070026-S079 | CERAMAX Ceramic Total Hip System | Normal 180 Day Track No User Fee | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-02-22 | P070026-S091 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-02-14 | P070026-S090 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2022-01-21 | P070026-S089 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2021-12-09 | P070026-S088 | CERAMAX (R) Ceramic Total Hip System | Special (Immediate Track) | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2021-11-05 | P070026-S087 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2021-09-10 | P070026-S085 | CERAMAX® Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2021-08-19 | P070026-S084 | CERAMAX® Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2021-07-20 | P070026-S083 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2021-07-07 | P070026-S082 | CERAMAX Ceramic Total Hip System | Special (Immediate Track) | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2021-05-05 | P070026-S081 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2021-04-30 | P070026-S080 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-11-30 | P070026-S078 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-11-19 | P070026-S077 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-10-05 | P070026-S076 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-07-21 | P070026-S070 | CERAMAX Ceramic Total Hip System | Normal 180 Day Track No User Fee | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-07-15 | P070026-S075 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-07-08 | P070026-S073 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-06-26 | P070026-S072 | Ceramax Ceramic Total Hip System | Normal 180 Day Track No User Fee | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-06-24 | P070026-S074 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| 2020-04-22 | P070026-S071 | CERAMAX Ceramic Total Hip System | 30-Day Notice | MRA | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-03-12 | Class II | Ongoing | Z-1456-2024 | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen… | — | Product incorrectly labelled. |
| 2023-02-15 | Class II | Ongoing | Z-1267-2023 | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507 | — | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gam… |
| 2023-02-15 | Class II | Ongoing | Z-1266-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312 | — | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gam… |
| 2023-02-15 | Class II | Ongoing | Z-1265-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226 | — | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gam… |
| 2023-02-15 | Class II | Ongoing | Z-1264-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212 | — | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gam… |
| 2023-02-15 | Class II | Ongoing | Z-1263-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 | — | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gam… |
| 2022-06-29 | Class II | Ongoing | Z-1419-2022 | ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the f… | — | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTU… |
| 2022-05-18 | Class II | Ongoing | Z-1375-2022 | MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136… | — | The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated… |
| 2022-03-11 | Class II | Terminated | Z-1029-2022 | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | — | System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restar… |
| 2022-01-05 | Class II | Terminated | Z-0632-2022 | ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surge… | — | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occu… |
| 2022-01-05 | Class II | Terminated | Z-0631-2022 | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision … | — | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occu… |
| 2021-12-07 | Class II | Terminated | Z-0490-2022 | GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 | — | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone da… |
| 2021-12-07 | Class II | Terminated | Z-0489-2022 | GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 | — | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone da… |
| 2021-12-07 | Class II | Terminated | Z-0488-2022 | GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 | — | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone da… |
| 2021-12-07 | Class II | Terminated | Z-0487-2022 | GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 | — | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone da… |
| 2021-12-07 | Class II | Terminated | Z-0486-2022 | GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 | — | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone da… |
| 2021-12-07 | Class II | Terminated | Z-0485-2022 | GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 | — | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone da… |
| 2021-12-07 | Class II | Terminated | Z-0484-2022 | GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100 | — | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone da… |
| 2021-12-07 | Class II | Terminated | Z-0483-2022 | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | — | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone da… |
| 2021-09-09 | Class II | Terminated | Z-0074-2022 | ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001 | — | Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery |
| 2021-08-10 | Class II | Terminated | Z-2400-2021 | TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical … | — | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may… |
| 2021-08-10 | Class II | Terminated | Z-2399-2021 | TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical … | — | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may… |
| 2021-08-10 | Class II | Terminated | Z-2398-2021 | TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical … | — | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may… |
| 2021-08-10 | Class II | Terminated | Z-2397-2021 | TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgica… | — | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may… |
| 2021-08-10 | Class II | Terminated | Z-2396-2021 | TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical … | — | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may… |
| 2021-08-10 | Class II | Terminated | Z-2395-2021 | TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical … | — | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may… |
| 2021-08-10 | Class II | Terminated | Z-2394-2021 | TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical… | — | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may… |
| 2021-07-01 | Class II | Terminated | Z-2348-2021 | ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080 | — | Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement |
| 2021-05-07 | Class II | Terminated | Z-1845-2021 | DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365… | — | Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product. |
| 2021-02-22 | Class II | Terminated | Z-1316-2021 | The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replac… | — | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utili… |
| 2021-02-22 | Class II | Terminated | Z-1315-2021 | The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components inten… | — | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utili… |
| 2021-02-22 | Class II | Terminated | Z-1314-2021 | ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components d… | — | Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utili… |
| 2021-01-08 | Class II | Terminated | Z-1103-2021 | Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and L… | — | The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. |
| 2020-12-15 | Class II | Terminated | Z-0802-2021 | Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 12… | — | Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without … |
| 2020-01-03 | Class II | Terminated | Z-1169-2020 | SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block. | — | The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-04 | K262130 | ATTUNE Revision Knee System | JWH | Class II | Orthopedic |
| 2026-05-22 | K252887 | DePuy ATTUNE Knee System | OIY | Class II | Orthopedic |
| 2023-08-22 | K231503 | CUPTIMIZE Advanced | LLZ | Class II | Radiology |
| 2022-01-06 | K213839 | DePuy Corail AMT Hip Prosthesis | LZO | Class II | Orthopedic |
| 2021-02-19 | K210167 | DELTA XTEND Reverse Shoulder System | PHX | Class II | Orthopedic |
| 2020-11-19 | K203167 | DePuy Corail AMT Hip Prosthesis | LZO | Class II | Orthopedic |
| 2020-10-21 | K202472 | ACTIS Duofix Hip Prosthesis | LPH | Class II | Orthopedic |
| 2020-06-18 | K201347 | DePuy ATTUNE Total Knee System | OIY | Class II | Orthopedic |
| 2020-06-16 | K193540 | TRUMATCH Personalized Solutions | JWH | Class II | Orthopedic |
| 2020-02-04 | K193398 | Summit DuoFix HA Coating | MEH | Class II | Orthopedic |