Zimmer Biomet recalls hip fracture nails with set screw that won't advance or reverse, potentially causing improper fixation. Affected models include 130¿ 9 mm x 380 mm, item 814509380.
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 healing.
The set screw in the nail cannot move forward or backward from its starting position. This prevents the nail from being properly secured in the bone, which could lead to the nail loosening or failing during healing.
Orthopedic surgeons and medical staff who use Zimmer Biomet's Affixus Hip Fracture Nails for hip fracture repairs are affected. Patients receiving these nails during surgery are at risk if the set screw malfunctions.
Check for the model name 'Affixus Hip Fracture Nail Right 130¿ 9 mm x 380 mm' and item number 814509380. The product was sold under these specific identifiers.
Verify the model and item number to confirm if your nail is affected.
The recall indicates a potential issue with the set screw not advancing or reversing, which could lead to improper fixation. However, the hazard is described as low risk in this context.
Check for the model name 'Affixus Hip Fracture Nail Right 130¿ 9 mm x 380 mm' and item number 814509380.
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-3115-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3115-2018 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.
