DePuy Synthes recalls 15.0MM 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 15.0MM reamer heads for RIA 2 surgical use because they can break more than expected if surgeons don't follow proper techniques, risking tissue damage, soft tissue injury, or bone damage.
The reamer heads can break more frequently than expected when surgeons don't follow proper techniques. This breakage can cause tissue damage, soft tissue injury, or bone damage during surgery.
Orthopedic surgeons and medical professionals who use these instruments during surgery are most at risk if they don't follow recommended surgical techniques.
Check for the part code 03.404.026S on the reamer head. These instruments were sold with the UDI 10886982273956 and are used in RIA 2 surgical procedures.
Inspect the reamer head for signs of damage or deformation before use.
The recall applies to surgical instruments used during procedures. If you are a surgeon using these specific reamer heads without following recommended techniques, you may be affected.
Look for the part code 03.404.026S on the reamer head. These instruments were sold with the UDI 10886982273956 and are used in RIA 2 surgical procedures.
The recall does not specify a remedy, so check with your surgeon or the manufacturer for guidance on safe use or disposal.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0581-2021 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0581-2021 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.
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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.
