DePuy Synthes recalls 13.0MM RIA 2 reamer heads for potential breakage during surgery, causing tissue damage if improper techniques are used. Affected units include specific part code and all 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 13.0MM RIA 2 reamer heads for orthopedic surgery that could break during use, leading to tissue damage or bone injury if surgical techniques aren't followed properly. This recall affects surgeons and surgical teams using the specific part code.
The reamer head can break more often than expected during surgery if the recommended techniques aren't followed correctly. This breakage may cause tissue damage, soft tissue injury, or bone damage to the patient.
Surgeons and surgical teams using the DePuy Synthes 13.0MM RIA 2 reamer heads for orthopedic procedures are most at risk. The recall applies to all units with the specific part code.
Check for the part code 03.404.022S on the reamer head. All lots of this specific surgical instrument are affected, including those with the unique identifier UDI: 10886982274021.
Look for the part code 03.404.022S on the reamer head and the unique identifier UDI: 10886982274021.
The reamer head can break more than expected during surgery if surgical techniques aren't followed properly, potentially causing tissue damage, soft tissue injury, or bone damage.
Check for the part code 03.404.022S and unique identifier UDI: 10886982274021. If you have the affected product, contact DePuy Synthes for guidance.
The recall record does not specify a remedy or fix. Affected users should check with DePuy Synthes for further instructions.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0577-2021 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0577-2021 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.
