DePuy Synthes recalls 13.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage. Affected units include all lots with specific part code.
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
DePuy Synthes is recalling 13.5MM reamer heads for RIA 2 surgical instruments because they can break more often than expected if surgeons don't follow proper techniques. This breakage might cause tissue damage, soft tissue injury, or bone damage during surgery.
The reamer heads can break more frequently than expected when surgical techniques aren't followed correctly. This breakage may cause tissue damage, soft tissue injury, or bone damage during procedures.
Orthopedic surgeons and surgical teams using the DePuy Synthes 13.5MM reamer heads for RIA 2 instruments are most at risk. The recall affects all units with the specific part code.
Check for the part code 03.404.023S on the reamer head. All lots of this instrument are affected, with a unique device identifier (UDI) starting with 10886982274045.
Ensure surgical techniques follow the manufacturer's recommendations to prevent reamer head breakage.
No, this recall specifically affects DePuy Synthes 13.5MM reamer heads for RIA 2 surgical instruments used in orthopedic procedures.
Look for the part code 03.404.023S and the unique device identifier (UDI) starting with 10886982274045 on the reamer head.
Follow proper surgical techniques as recommended by the manufacturer to prevent breakage. No immediate action is required beyond ensuring correct usage.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0578-2021 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0578-2021 from DePuy Synthes. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
