DePuy Synthes recalls 16.5MM 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 16.5MM 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 heads can break more frequently than expected when surgeons don't follow the recommended techniques. This breakage can lead to adverse tissue reactions, soft tissue damage, or bone damage during surgery.
Orthopedic surgeons and medical professionals using these instruments during surgery are most at risk if they don't follow recommended surgical techniques.
Check for the part code 03.404.029S on the reamer head. All lots of this instrument are affected, with a unique device identifier (UDI) of 10886982274038.
Look for the part code 03.404.029S and unique device identifier (UDI) 10886982274038 on the reamer head.
The reamer head can break more frequently than expected when surgeons don't follow recommended techniques, which might cause tissue damage, soft tissue injury, or bone damage.
The official recall notice does not specify a remedy or action steps for affected users.
The recall states that breakage can cause tissue damage, soft tissue injury, or bone damage if recommended surgical techniques are not followed.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0584-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0584-2021 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.
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.
