DePuy Synthes recalls 10.0MM RIA 2 reamer heads due to breakage risk when surgical techniques aren't followed, potentially causing tissue damage. Affected items have part code 03.404.016S and all lots.
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 10.0MM 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 often than expected during surgery. If the surgeon doesn't follow proper techniques, this breakage may cause tissue damage, soft tissue injury, or bone damage.
Orthopedic surgeons and surgical teams using these instruments during procedures. Those who follow recommended surgical techniques are at lower risk.
Check for the part code 03.404.016S on the instrument. All lots of this specific reamer head are affected, with UDI: 10886982273932.
Inspect the reamer head for signs of damage or deformation before use.
Yes, the recall states that breakage risk is reduced when recommended surgical techniques are followed.
The recall record does not specify actions for broken instruments.
Look for part code 03.404.016S and UDI: 10886982273932 on the instrument.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0571-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0571-2021 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.
