Zimmer Biomet recalls hip fracture nails with set screw that won't advance or reverse, potentially causing improper fixation. Affected models include left 125mm 9mm x 460mm, item 814409460.
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 advance or reverse properly. This could lead to improper fixation of the hip fracture, risking complications during surgery or recovery.
The set screw in the nail cannot move forward or backward from its starting position. This may prevent the nail from being properly secured in the bone, which could lead to improper fracture fixation during surgery or after the procedure.
Surgical patients who received the specific hip fracture nail model (left 125mm 9mm x 460mm, item 814409460) from Zimmer Biomet. Surgeons and medical staff using this model during procedures are most at risk.
Check for the product name 'Affixus Hip Fracture Nail Left 125mm 9mm x 460mm' and item number 814409460. The recall applies to specific surgical models sold by Zimmer Biomet.
Reach out to Zimmer Biomet directly to confirm if your specific nail model is affected and get guidance on next steps.
The recall states the set screw may not advance or reverse properly, which could lead to improper fixation. However, the hazard is described as a potential issue during surgery, not an immediate risk to the user.
Check for the product name 'Affixus Hip Fracture Nail Left 125mm 9mm x 460mm' and item number 814409460. The recall applies to specific surgical models sold by Zimmer Biomet.
Contact Zimmer Biomet directly to confirm if your specific nail model is affected and get guidance on next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3088-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3088-2018 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.