DePuy Synthes recalls 15.5mm 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 15.5mm reamer heads for RIA 2 surgical instruments because they can break more often than expected if surgeons don't follow proper techniques. This breakage might cause tissue damage, soft tissue injury, or bone damage during surgery.
The reamer heads can break more frequently than expected when surgeons don't follow the correct surgical procedures. This breakage may cause tissue damage, soft tissue injury, or bone damage during surgery.
Surgical teams using DePuy Synthes 15.5mm reamer heads for RIA 2 instruments are affected. Surgeons who do not follow recommended techniques face the highest risk of injury.
Check for the part code 03.404.027S on the reamer head. All lots of this instrument are affected, with a unique device identifier (UDI) of 10886982273994.
Inspect the reamer head for signs of damage or unusual wear that might indicate breakage risk.
No, this recall is specific to the 15.5mm reamer heads for RIA 2 surgical instruments with part code 03.404.027S.
The recall states that breakage can cause tissue damage, soft tissue injury, or bone damage if proper surgical techniques are not followed.
Look for the part code 03.404.027S on the reamer head. All lots of this instrument are affected, with a unique device identifier (UDI) of 10886982273994.
We’ve drafted a message you can send DePuy Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0582-2021 — DePuy Synthes DePuy Synthes Hello, I own a DePuy Synthes that is covered by recall Z-0582-2021 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.
