Zimmer Biomet recalls Affixus Hip Fracture Nails with set screw that won't advance or reverse, posing a risk of improper fixation during hip fracture surgery.
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 fixation of the hip fracture, potentially causing complications during surgery.
The set screw in the nail cannot advance or reverse from its original position. This may prevent proper fixation of the hip fracture during surgery, potentially leading to complications or the need for additional procedures.
Surgical patients who received the recalled Affixus Hip Fracture Nails (model 125, 9 mm x 320 mm) from Zimmer Biomet. Surgeons and medical staff using these specific implants are most at risk.
Check for the Affixus Hip Fracture Nail Right 125 (9 mm x 320 mm) with item number 814309320. This model was sold in the U.S. and is used in hip fracture surgery.
Verify the item number and model on the nail to confirm if it is the recalled version.
The recall is for a set screw that won't advance or reverse, which could lead to improper hip fracture fixation during surgery. However, the hazard is not described as causing serious injury in normal use.
The recall record does not specify a remedy, so no action is required beyond checking if you have the recalled model.
Look for the Affixus Hip Fracture Nail Right 125 (9 mm x 320 mm) with item number 814309320.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3049-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3049-2018 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.
