DePuy Synthes recalls 11.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage.
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 11.5MM reamer heads for RIA 2 surgical instruments because they can break more than expected if used incorrectly, leading to tissue damage or bone issues. This affects surgeons and medical staff who use these instruments during orthopedic procedures.
The reamer heads can break more frequently than expected when surgical techniques aren't followed properly. This breakage may cause tissue damage, soft tissue injury, or bone damage during orthopedic surgery.
Surgeons and medical staff who use these orthopedic instruments during procedures are most at risk. The recall applies to all units sold with the specific part code.
Check for the part code 03.404.019S on the instrument. All units sold with this part code are affected, including those with the UDI 10886982273970.
Look for the part code 03.404.019S on the reamer head to confirm it is affected.
The reamer head can break more than expected when surgical techniques aren't followed properly, potentially causing tissue damage or bone issues.
Check for the part code 03.404.019S to confirm it is affected. No specific action is required beyond verification.
Yes, if the reamer head breaks during use, it can cause tissue damage, soft tissue injury, or bone damage.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0574-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0574-2021 from 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.
