Zimmer Biomet recalls specific hip fracture nail models due to set screw malfunction. Affected items may not advance or reverse properly, requiring immediate action.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling certain hip fracture nail models because the set screw can't move correctly. This could lead to improper fixation of the hip fracture, risking complications during healing.
The set screw in the nail fails to advance or reverse from its original position. This means the nail may not hold securely in the bone, potentially causing the implant to shift during healing or movement.
Orthopedic surgeons and medical staff using the Affixus Hip Fracture Nail Left 130 model (15 mm x 360 mm) for hip fracture repairs. Patients receiving this specific implant are at risk of improper healing.
Check for the model name 'Affixus Hip Fracture Nail Left 130', size 15 mm x 360 mm, and item number 814615360. The product was sold in specific quantities with the item number 791930.
Verify the model, size, and item number to confirm if your product is affected.
The recall is for a potential issue with the set screw not advancing or reversing, which could affect proper fixation. However, the hazard level is low risk as the remedy is not specified and the issue may not cause serious injury in normal use.
The recall record does not specify a remedy, so there is no action required beyond checking if your product matches the affected model.
Check for the model name 'Affixus Hip Fracture Nail Left 130', size 15 mm x 360 mm, and item number 814615360.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3174-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3174-2018 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.