DePuy Synthes recalls 16.0MM reamer heads for RIA 2 surgical use 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 16.0MM 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 orthopedic surgeons and their patients during specific surgeries.
The reamer head can break more frequently than expected if surgical techniques aren't followed properly. This breakage may cause tissue damage, soft tissue injury, or bone damage during surgery.
Orthopedic surgeons and patients using this surgical instrument during RIA 2 procedures. Those who follow recommended techniques are at lower risk.
Check for the part code 03.404.028S on the reamer head. All lots of this instrument are affected, with a unique device identifier (UDI) starting with 10886982274014.
Inspect the reamer head for signs of damage or unusual wear that might indicate breakage risk.
Ensure proper surgical techniques are used to minimize the risk of breakage and associated injuries.
This recall applies to orthopedic surgeons using the specific reamer head during RIA 2 procedures. If you follow recommended techniques, the risk is low.
Look for the part code 03.404.028S and the unique device identifier (UDI) starting with 10886982274014 on the reamer head.
The recall does not require immediate action, but surgeons should check for breakage and follow proper surgical techniques to reduce risk.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0583-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0583-2021 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.
