DePuy Synthes recalls 14.5MM 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 14.5MM reamer heads for RIA 2 surgical instruments because they can break more often 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 head can break more frequently than expected when surgical techniques are not followed correctly. This breakage may cause tissue damage, soft tissue injury, or bone damage during procedures.
Surgeons and medical staff who use DePuy Synthes RIA 2 orthopedic instruments are most at risk if they do not follow proper surgical techniques.
Check for the part code 03.404.025S on the reamer head. The product was sold with all lots and has a unique device identifier (UDI) starting with 10886982274083.
Inspect the reamer head for signs of damage or unusual wear that could indicate breakage risk.
The reamer head can break more often than expected when surgical techniques are not followed correctly, potentially causing tissue damage or bone issues.
Look for the part code 03.404.025S on the reamer head. The product was sold with all lots and has a unique device identifier (UDI) starting with 10886982274083.
The recall does not specify a remedy, so contact DePuy Synthes directly for guidance on next steps.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0580-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0580-2021 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.
