DePuy Orthopaedics, Inc.
105 recalls on record · Latest: Mar 29, 2023
FDA Devices Moderate Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
FDA Devices Moderate Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
FDA Devices Moderate Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
FDA Devices Moderate Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
FDA Devices Moderate Jul 27, 2022
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: …
FDA Devices Moderate May 11, 2022
VELYS Robotic-Assisted Solution Base Product No.: 451570100
FDA Devices Moderate Feb 16, 2022
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 15…
FDA Devices Moderate Jan 19, 2022
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
FDA Devices Moderate Jan 19, 2022
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
FDA Devices Moderate Jan 19, 2022
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
FDA Devices Moderate Jan 19, 2022
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
FDA Devices Moderate Oct 13, 2021
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
FDA Devices Moderate Sep 8, 2021
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …
FDA Devices Moderate Sep 8, 2021
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …
FDA Devices Moderate Sep 8, 2021
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist i…
FDA Devices Moderate Sep 8, 2021
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in …
FDA Devices Moderate Sep 1, 2021
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
FDA Devices Moderate Apr 7, 2021
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natura…
FDA Devices Moderate Apr 7, 2021
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and pa…
FDA Devices Moderate Apr 7, 2021
The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, t…
FDA Devices Moderate Feb 17, 2021
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
FDA Devices Moderate Jan 13, 2021
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 1…
FDA Devices Moderate Feb 19, 2020
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
FDA Devices Moderate Apr 17, 2019
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in C…
FDA Devices Moderate Apr 17, 2019
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL t…
FDA Devices Moderate Apr 17, 2019
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAI…
FDA Devices Moderate Sep 5, 2018
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
FDA Devices Moderate Aug 1, 2018
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
FDA Devices Moderate May 16, 2018
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
FDA Devices Moderate May 16, 2018
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
FDA Devices Moderate Apr 4, 2018
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left…
FDA Devices Moderate Mar 14, 2018
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumb…
FDA Devices Moderate Mar 14, 2018
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
FDA Devices Moderate Mar 7, 2018
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacemen…
FDA Devices Moderate Mar 7, 2018
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replac…
FDA Devices Moderate Feb 21, 2018
CORAIL HIGH OFFSET STEM Collarless SIZE 14
FDA Devices Moderate Jun 14, 2017
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
FDA Devices Moderate Dec 14, 2016
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
FDA Devices Moderate Oct 14, 2015
Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revi…
FDA Devices Moderate Jul 29, 2015
ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to functio…
FDA Devices Moderate Jul 29, 2015
ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function…
FDA Devices Moderate Jul 29, 2015
ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to functio…
FDA Devices Moderate Jul 29, 2015
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to functi…
FDA Devices Moderate Jun 3, 2015
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
FDA Devices Moderate Jun 3, 2015
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
FDA Devices Moderate Mar 11, 2015
SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing …
FDA Devices Moderate Jan 21, 2015
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several rela…
FDA Devices Moderate Jan 14, 2015
Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. Th…
FDA Devices Moderate Jan 14, 2015
Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedure…
FDA Devices Moderate Jan 14, 2015