DePuy Synthes recalls 12.5mm reamer heads for RIA 2 surgical use due to breakage risk causing soft tissue damage if improper techniques are used. Affected units have specific part code and lot numbers.
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 12.5mm reamer heads for RIA 2 surgical procedures because they can break more often than expected, potentially causing soft tissue damage, bone damage, or adverse tissue reactions if surgeons don't follow proper techniques.
The reamer heads can break more frequently than expected during surgery. If surgeons don't follow recommended techniques, this breakage may cause soft tissue damage, bone damage, or adverse tissue reactions.
Orthopedic surgeons using the DePuy Synthes 12.5mm reamer heads for RIA 2 procedures are most at risk. The recall affects specific surgical instruments with the part code 03.404.021S.
Check for the part code 03.404.021S on the instrument. All units with this part code are affected, regardless of lot number or UDI.
Inspect the reamer head for signs of damage or excessive wear that could lead to breakage during use.
The reamer head can break more frequently than expected, potentially causing soft tissue damage, bone damage, or adverse tissue reactions if surgeons don't follow recommended surgical techniques.
Check for the part code 03.404.021S. If you have this part, inspect it for damage and follow proper surgical techniques to minimize breakage risk.
The recall record does not mention any remedy or replacement options.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0576-2021 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0576-2021 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.
