Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These Recalled by DePuy Orthopaedics, Inc. Due to Products were made outside of Quality System Regulation,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Orthopaedics, Inc. directly.
Affected Products
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
Quantity: 345
Why Was This Recalled?
Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. has 154 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report