DePuy Orthopaedics, Inc. Recalls

All product recalls associated with DePuy Orthopaedics, Inc..

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Recall Summary

Total Recalls

77

Past Year

0

Class I (Serious)

0

Most Recent

Mar 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 77 recalls

ATTUNE AFFIXIUM Knee (DePuy) – Incorrect Labeling (2024)

Product incorrectly labelled.

FDAMar 12, 2024Nationwide• DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc.: Attune Revision Limb Preservation System (LPS) Tibial Ins...

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

FDAFeb 15, 2023Nationwide• DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc.: Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ...

The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.

FDA

Feb 15, 2023

Nationwide

• DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc.: ATTUNE Measured Sizing and Rotation Guide-to size the fem...

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 ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

FDAJun 29, 2022Nationwide• DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc.: MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60...

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 to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.

FDAMay 18, 2022Nationwide• DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc.: 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 restart the system and potentially cause a delay in treatment

FDAMar 11, 2022Nationwide• DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc.: ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-inte...

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

FDAJan 5, 2022Nationwide• DePuy Orthopaedics, Inc.

DePuy Orthopaedics, Inc.: ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended...

May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

FDAJan 5, 2022Nationwide• DePuy Orthopaedics, Inc.