DePuy Synthes recalls 12.0MM reamer heads for RIA 2 surgical use due to breakage risk when improper techniques are applied, 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 12.0MM reamer heads for RIA 2 surgical procedures because they can break more often than expected if used incorrectly, leading to tissue damage or bone injury. This affects orthopedic surgeons and their patients during specific surgeries.
The reamer head can break more frequently than normal when surgical techniques aren't followed correctly. This breakage may cause tissue damage, soft tissue injury, or bone damage during procedures.
Orthopedic surgeons and patients undergoing RIA 2 procedures using this specific reamer head. Surgeons using improper techniques are at higher risk of complications.
Check for the part code 03.404.020S on the reamer head. All lots of this product are affected, with a unique device identifier (UDI) of 10886982273987.
Inspect the reamer head for signs of damage or unusual wear that might indicate breakage risk.
No, this reamer head can break more often than expected if used incorrectly, leading to tissue or bone damage.
The recall does not specify a remedy, so contact DePuy Synthes directly for guidance.
Look for the part code 03.404.020S and the unique device identifier (UDI) 10886982273987 on the reamer head.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0575-2021 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0575-2021 from DePuy 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
