DePuy Synthes recalls 10.5MM 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 10.5MM reamer heads for RIA 2 surgical instruments because they can break more often than expected if surgeons don't follow proper techniques, which might cause tissue damage, soft tissue injury, or bone damage.
The reamer head can break more frequently than expected if surgical techniques aren't followed correctly. This breakage may cause tissue damage, soft tissue injury, or bone damage during procedures.
Surgical teams using DePuy Synthes 10.5MM reamer heads for RIA 2 instruments are affected. Surgeons who don't follow recommended techniques face the highest risk of injury.
Check for the part code 03.404.017S on the reamer head. The product was sold with all lots and has a unique device identifier (UDI) starting with 10886982273949.
Inspect the reamer head for signs of damage or unusual wear that might indicate breakage risk.
The product is safe if surgeons follow recommended techniques. Breakage can occur if techniques are not followed correctly.
The official recall notice does not specify a remedy or action steps for consumers. Check with your surgeon for guidance.
Look for the part code 03.404.017S on the reamer head. The product was sold with all lots and has a unique device identifier (UDI) starting with 10886982273949.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0572-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0572-2021 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.
