DePuy Synthes recalls 18.0MM RIA 2 reamer heads due to breakage risk when surgical techniques aren't followed, potentially causing tissue damage. Affected items 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 18.0MM RIA 2 reamer heads for orthopedic surgery. Breakage can cause tissue damage or bone injury if surgeons don't follow proper techniques.
The reamer head can break more often than expected during surgery. If surgeons don't follow recommended techniques, this breakage can cause tissue damage, soft tissue injury, or bone damage.
Orthopedic surgeons using these reamer heads during surgery are most at risk. Patients receiving this surgical instrument may be affected if the procedure isn't performed correctly.
Check for the part code 03.404.032S on the reamer head. All lots of this product are affected, with UDI number 10886982274090.
Look for part code 03.404.032S and UDI number 10886982274090 on the reamer head.
The reamer head can break more than expected during surgery, potentially causing tissue damage or bone injury if surgical techniques aren't followed correctly.
The official recall notice doesn't specify a remedy or action for affected items.
The hazard description mentions tissue damage and bone injury, but the recall doesn't specify if these injuries are serious or life-threatening.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0587-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0587-2021 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.
