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All Recalls

Every Depuy Orthopaedics, Inc. Recall

Sorted by most recent. Click any recall for full details.

105 recalls
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Medical Devices·7 affected·Feb 15, 2023
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant P...
Medical Implants·872 affected·Jun 29, 2022
High RiskFDA
Depuy Orthopaedics, Inc.
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Medical Devices·68 affected·Mar 11, 2022
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Produc...
Medical Devices·6 affected·Jan 5, 2022
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Medical Devices·3 affected·Dec 7, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Medical Devices·140 affected·Dec 7, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Medical Devices·781 affected·Dec 7, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Medical Devices·870 affected·Dec 7, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Medical Devices·10 affected·Sep 9, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices·5 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices·6 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation...
Surgical Devices·2 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices·2 affected·Aug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Medical Devices·7 affected·Jul 1, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replac...
Medical Implants·102 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, ti...
Medical Devices·355 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace th...
Medical Devices·102 affected·Feb 22, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Medical Devices·60 affected·Jan 8, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050...
Medical Implants·14,161 affected·Dec 15, 2020
High RiskFDA
Depuy Orthopaedics, Inc.
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Medical Devices·140 affected·Jan 3, 2020
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instrumen...
Surgical Devices·12,639 affected·Sep 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used...
Surgical Devices·12,639 affected·Sep 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments u...
Surgical Devices·12,639 affected·Sep 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Medical Devices·1 affected·Jul 18, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Medical Devices·0 affected·Jun 21, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Medical Implants·1 affected·Apr 16, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Medical Implants·2 affected·Apr 16, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2...
Medical Devices·2,110 affected·Dec 21, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulde...
Medical Implants·0 affected·Aug 31, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-sho...
Medical Implants·23,053 affected·Aug 31, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use...
Medical Devices·130 affected·Jul 26, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar sp...
Medical Devices·130 affected·Jul 26, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL HIGH OFFSET STEM Collarless SIZE 14
Medical Devices·19 affected·Jul 12, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Medical Devices·345 affected·Jan 6, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Medical Devices·1 affected·Nov 8, 2016
High RiskFDA
Depuy Orthopaedics, Inc.
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both prim...
Medical Devices·7,488 affected·Sep 8, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim componen...
Medical Devices·11,360 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component...
Medical Devices·42,645 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim componen...
Medical Devices·34,676 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim compone...
Medical Devices·36,607 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
Medical Implants·28,732 affected·Mar 4, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Medical Implants·19,059 affected·Mar 4, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used f...
Medical Implants·1,267 affected·Feb 11, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole prepa...
Surgical Devices·1,130 affected·Nov 12, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement pr...
Surgical Devices·4,555 affected·Nov 10, 2014