Zimmer Biomet recalls Affixus Hip Fracture Nail Right 125 (11mm x 420mm) 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 a specific hip fracture nail model 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 cannot advance or reverse from its original position. This means the nail might not hold securely in the bone, potentially causing the fracture to shift or fail during healing.
Orthopedic surgeons and patients who have purchased the Affixus Hip Fracture Nail Right 125 (11mm x 420mm) with item number 814311420. Patients using this nail for hip fracture repair are at risk of improper fixation.
Check for the product name 'Affixus Hip Fracture Nail Right 125' with dimensions 11 mm x 420 mm and item number 814311420. This model was sold starting from 2009.
Verify the item number 814311420 and model specifications to confirm if your nail is affected.
The recall indicates the set screw may not advance or reverse properly, which could lead to improper fixation of the hip fracture. However, the hazard is not described as causing serious injury in normal use.
Check for the product name 'Affixus Hip Fracture Nail Right 125' with dimensions 11 mm x 420 mm and item number 814311420.
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-3063-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3063-2018 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.