Zimmer Biomet recalls hip fracture nails with set screw that cannot advance or reverse, potentially causing improper fixation. Affected models include left 125mm 11mm x 460mm, item 814: 814411460.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling hip fracture nails that have a set screw which won't move properly. This could lead to improper bone fixation during surgery, risking complications for patients.
The set screw in the nail cannot advance or reverse from its original position. This means the nail might not stay securely in place during surgery, potentially causing improper bone fixation and complications.
Surgical patients who received the specific hip fracture nail model (left 125mm, 11mm x 460mm) from Zimmer Biomet. Surgeons and hospitals using this model are most at risk.
Check for the model: left 125mm, 11mm x 460mm, item number 814411460. The product was sold under the Affixus Hip Fracture Nail name.
Verify the model and item number to confirm if your nail is affected.
The set screw cannot advance or reverse, which may cause improper bone fixation during surgery. This is a potential risk but not an immediate danger for all users.
Check for the model: left 125mm, 11mm x 460mm, item number 814411460.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3097-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3097-2018 from Zimmer 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.
