DePuy Synthes recalls 17.0MM 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 17.0MM reamer heads for RIA 2 surgical instruments because they can break more often than expected if used incorrectly, which might cause tissue damage, soft tissue injury, or bone damage.
The reamer heads can break more frequently than expected when surgical techniques aren't followed properly. This breakage can lead to tissue damage, soft tissue injury, or bone damage during surgery.
Orthopedic surgeons and surgical staff who use these instruments during procedures are most at risk if they don't follow recommended techniques.
Look for the product name '17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument' with part code 03.404.030S. All lots are affected.
Verify the part code 03.404.030S and that it's a 17.0MM reamer head for RIA 2 surgical instruments.
The reamer heads can break more frequently than expected when surgical techniques aren't followed properly, which might cause tissue damage, soft tissue injury, or bone damage.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
The hazard description mentions potential tissue damage, soft tissue injury, or bone damage, but does not specify if serious injury is possible in normal use.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0585-2021 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0585-2021 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.
