Biomet recalls specific orthopedic implants for humeral reconstruction due to assembly failure risk. The mismatched screw holes may prevent proper screw engagement during surgery in less than 1% of cases.
During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.
Biomet is recalling certain orthopedic implants used for humeral reconstruction because a mismatch in screw holes can cause assembly failure during surgery. If the implant has already been implanted, no action is required.
The SRS Humeral Distal Body implant has screw holes that don't align correctly with the Discovery Elbow System Humeral Condyle. This mismatch can prevent proper screw engagement during surgery in less than 1% of cases, but does not cause injury if the implant has already been implanted.
Patients who received the recalled implants for proximal humeral reconstruction are not at risk. Surgeons using the specific model numbers and lot codes listed in the recall may need to check assembly compatibility.
Check for model numbers 211250-211255 and lot codes listed in the recall. The recall includes specific items with UDI codes starting with 00880304850316 or 00880304850330.
If the implant has already been implanted, no action is required. Otherwise, contact your surgeon to verify assembly compatibility.
No action is required if the implant has already been implanted.
Model numbers 211250-211255 and specific lot codes listed in the recall.
The mismatch is estimated to prevent screw engagement in less than 1% of cases.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-1173-2018 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-1173-2018 from Biomet. 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.
