Recall archive
55 recalls · page 1 of 3
Reported Apr 10, 2024
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Product incorrectly labelled.
FDA (openFDA device enforcement)
Reported Mar 29, 2023
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 27, 2022
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode…
FDA (openFDA device enforcement)
Reported Jul 20, 2022
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported May 11, 2022
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Feb 16, 2022
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 19, 2022
GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
FDA (openFDA device enforcement)
Reported Sep 8, 2021
TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 1, 2021
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
FDA (openFDA device enforcement)
Reported Jun 16, 2021
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand · Product · Product details — Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
FDA (openFDA device enforcement)
Reported Apr 7, 2021
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 17, 2021
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
FDA (openFDA device enforcement)
Reported Jan 13, 2021
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the…
FDA (openFDA device enforcement)
Reported Feb 19, 2020
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
FDA (openFDA device enforcement)
Reported Apr 17, 2019
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — There is the potential for debris/material to be found behind the O-rings in the neck trials.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 5, 2018
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — This unit may be missing the screw/collet Assembly
FDA (openFDA device enforcement)
Reported Aug 1, 2018
CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics,…
FDA (openFDA device enforcement)
Reported May 16, 2018
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — There may be burrs on the extraction hole threads.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates…
FDA (openFDA device enforcement)
Reported Mar 21, 2018
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will…
FDA (openFDA device enforcement)
Reported Mar 14, 2018
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Potential for Intra-operative breakage of driver tips
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 7, 2018
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2018
CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Orthopaedics, Inc.
Matched: Brand — Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No.…
1 more product in this recall
FDA (openFDA device enforcement)
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