← Every firm
DePuy Orthopaedics, Inc. FDA Recalls
33 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee ReplacemenClass IIMar 12, 2024Product incorrectly labelled. |
| Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212Class IIFeb 15, 2023The subject product lots are being recalled because they rec |
| Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312Class IIFeb 15, 2023The subject product lots are being recalled because they rec |
| Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507Class IIFeb 15, 2023The subject product lots are being recalled because they rec |
| Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118Class IIFeb 15, 2023The subject product lots are being recalled because they rec |
| Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226Class IIFeb 15, 2023The subject product lots are being recalled because they rec |
| ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the fClass IIJun 29, 2022Manufactured with a Galvanized High Carbon Steel spring inst |
| MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136Class IIMay 18, 2022The Cathcart Ball has an inherent +5mm offset which is not c |
| VELYS Robotic-Assisted Solution Base Product No.: 451570100Class IIMar 11, 2022System software v1.5.1 has a system software issue related t |
| ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision Class IIJan 5, 2022May have adhesive residue on the posterior surface of the fe |
| ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeClass IIJan 5, 2022May have adhesive residue on the posterior surface of the fe |
| GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100Class IIDec 7, 2021Stems may have an undersized spigot bore diameter therefore |
| GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600Class IIDec 7, 2021Stems may have an undersized spigot bore diameter therefore |
| GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600Class IIDec 7, 2021Stems may have an undersized spigot bore diameter therefore |
| GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100Class IIDec 7, 2021Stems may have an undersized spigot bore diameter therefore |
| GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100Class IIDec 7, 2021Stems may have an undersized spigot bore diameter therefore |
| GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100Class IIDec 7, 2021Stems may have an undersized spigot bore diameter therefore |
| GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100Class IIDec 7, 2021Stems may have an undersized spigot bore diameter therefore |
| GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610Class IIDec 7, 2021Stems may have an undersized spigot bore diameter therefore |
| ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001Class IISep 9, 2021Packaging may include screws that are not intended to be use |
| TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical Class IIAug 10, 2021Software: A coding error associated with the Fast3D Segment |
| TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical Class IIAug 10, 2021Software: A coding error associated with the Fast3D Segment |
| TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical Class IIAug 10, 2021Software: A coding error associated with the Fast3D Segment |
| TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical Class IIAug 10, 2021Software: A coding error associated with the Fast3D Segment |
| TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgicalClass IIAug 10, 2021Software: A coding error associated with the Fast3D Segment |
| TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgicaClass IIAug 10, 2021Software: A coding error associated with the Fast3D Segment |
| TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical Class IIAug 10, 2021Software: A coding error associated with the Fast3D Segment |
| ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080Class IIJul 1, 2021Package labeled as 16mm x 80mm contained a 16mm x 130mm stem |
| DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365Class IIMay 7, 2021Fifty (50) individual units from Lot D20111130 were distribu |
| The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intenClass IIFeb 22, 2021Globally the company is removing 37 lots affected lots for M |
| ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components dClass IIFeb 22, 2021Globally the company is removing 37 lots affected lots for M |
| The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replacClass IIFeb 22, 2021Globally the company is removing 37 lots affected lots for M |
| Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LClass IIJan 8, 2021The taper dimensions may be out of specification due to a pr |