DePuy Synthes recalls 11.0MM RIA 2 reamer heads due to breakage risk when surgical techniques aren't followed, potentially causing tissue damage. Affected items have part code 03.404.018S and UDI 10886982273963.
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 11.0MM RIA 2 reamer heads for orthopedic surgery. Breakage can cause tissue damage, soft tissue injury, or bone damage if surgeons don't follow recommended techniques.
The reamer head can break more often than expected during surgery. If surgeons don't follow recommended techniques, this breakage may cause tissue damage, soft tissue injury, or bone damage.
Orthopedic surgeons and surgical teams using the DePuy Synthes 11.0MM RIA 2 reamer heads for procedures. Those who don't follow proper surgical techniques are at higher risk.
Check for part code 03.404.018S on the reamer head. All lots with UDI 10886982273963 are affected.
Inspect the reamer head for signs of damage or deformation before use.
The reamer head can break more often than expected during surgery, potentially causing tissue damage, soft tissue injury, or bone damage if surgeons don't follow recommended techniques.
Check for part code 03.404.018S and UDI 10886982273963. If you have the affected item, inspect it for damage before use.
The recall record does not mention a fix or remedy for this issue.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0573-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0573-2021 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.
