DePuy Synthes recalls 14.0MM RIA 2 reamer heads due to breakage risk when surgical techniques aren't followed, potentially causing tissue damage. Affected units have part code 03.404.024S and UDI 10886982274069.
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 14.0MM RIA 2 reamer heads for orthopedic surgery. Breakage can cause tissue damage, soft tissue injury, or bone damage if surgical techniques aren't followed properly.
The reamer head can break more than expected during surgery if proper techniques aren't used. This breakage may cause tissue damage, soft tissue injury, or bone damage to the patient.
Orthopedic surgeons and medical professionals using the reamer heads during surgery are most at risk. Patients receiving the surgery with these instruments could be affected.
Check for part code 03.404.024S on the reamer head. All units with UDI 10886982274069 are affected. The product is a sterile orthopedic surgical instrument.
Look for part code 03.404.024S and UDI 10886982274069 on the reamer head.
The part code is 03.404.024S.
Breakage can cause tissue damage, soft tissue injury, or bone damage if surgical techniques aren't followed properly.
Check for part code 03.404.024S and UDI 10886982274069 on the reamer head.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0579-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0579-2021 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.
