DePuy Synthes recalls 17.5MM reamer heads for RIA 2 surgical instruments due to breakage risk when improper techniques are used, potentially causing tissue damage. Affected units include specific part code and 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 17.5MM reamer heads for RIA 2 surgical instruments because they can break more than expected if used incorrectly, leading to tissue damage, soft tissue injury, or bone damage. This recall affects surgeons and medical professionals who use these instruments during orthopedic procedures.
The reamer heads 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.
Surgeons and medical professionals using DePuy Synthes 17.5MM reamer heads for RIA 2 orthopedic procedures are most at risk. The recall applies to specific surgical instruments used during orthopedic surgeries.
Check for the part code 03.404.031S on the reamer head. The recall covers all lots of this specific instrument used in RIA 2 orthopedic surgeries.
Inspect the reamer head for signs of damage or breakage before use.
Confirm the part code 03.404.031S and that it's part of the RIA 2 surgical instrument line.
The reamer head can break more than expected if surgical techniques aren't followed correctly, potentially causing tissue damage, soft tissue injury, or bone damage.
Check for breakage and verify the part code 03.404.031S. If it's affected, stop using it and contact DePuy Synthes for guidance.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0586-2021 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0586-2021 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.
