Zimmer Biomet recalls hip fracture nails with set screw that won't advance or reverse, posing a risk of improper fixation. Affected items include specific model numbers sold in 2022-2023.
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 after surgery.
The set screw in the nail cannot advance or reverse from its original position. This means the nail may not stay securely in place during healing, which could lead to improper fixation of the hip fracture.
Surgical patients who received the Affixus Hip Fracture Nail Right 125 model with item number 814309300 between 2022 and 2023 are affected. Patients who have had hip fracture surgery using this specific nail are most at risk.
Check for the model name 'Affixus Hip Fracture Nail Right 125' with dimensions 9 mm x 300 mm and item number 814309300. These items were sold between 2022 and 2023.
Verify the model number and dimensions 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.
Check for the model name 'Affixus Hip Fracture Nail Right 125', dimensions 9 mm x 300 mm, and item number 814309300. These items were sold between 2022 and 2023.
The recall does not specify a remedy, so contact Zimmer Biomet directly for further instructions.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3048-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3048-2018 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.