Zimmer Biomet recalls Affixus Hip Fracture Nail Right 130 (9mm x 440mm) due to set screw not advancing or reversing properly. Affected units may need replacement.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling Affix:us Hip Fracture Nail Right 130 models because the set screw can't move correctly. This could lead to improper fixation of the hip fracture, risking further injury.
The set screw in the nail cannot advance or reverse from its original position. This means the nail may not hold securely during surgery, potentially causing the implant to shift or fail after placement.
Orthopedic surgeons and medical facilities using the Affixus Hip Fracture Nail Right 130 models for hip fracture repairs are affected. Patients receiving this specific implant are at risk of improper fixation.
Check for the Affixus Hip Fracture Nail Right 130 (9mm x 440mm) with item number 814509440. The product was sold under specific model codes including 054150, 054170, 130740, 130750, 188310, 519480, 472970, and 503970.
Verify the item number and model codes listed in the recall notice to confirm if your device is affected.
The recall indicates a potential issue with the set screw not advancing or reversing properly, which could lead to improper fixation of the hip fracture. However, the hazard level is low risk as the remedy is not specified and the issue may not cause serious injury in normal use.
Check for the Affixus Hip Fracture Nail Right 130 (9mm x 440mm) with item number 814509440. Affected units include specific model codes: 054150, 054170, 130740, 130750, 188310, 519480, 472970, and 503970.
The recall notice does not specify a remedy, so no action is required at this time. Contact Zimmer Biomet directly for further 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-3118-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3118-2018 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.