Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic Recalled by Synthes (USA) Products LLC Due to RIA 2 reamer head breakage exceeds the expected...
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 Synthes (USA) Products LLC directly.
Affected Products
DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
Quantity: 1566 US ; 732 OUS
Why Was This Recalled?
RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Synthes (USA) Products LLC
Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report