Zimmer Biomet recalls Affixus Hip Fracture Nail Left 130 11mm x 400mm (Item 814611400) due to set screw malfunction. Affected units may not advance or reverse properly, potentially causing improper fixation.
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 its set screw cannot properly advance or reverse. This could lead to improper bone fixation during surgery, risking complications for patients.
The set screw in the nail fails to move correctly from its original position. This could cause the nail to not stay securely in place during bone healing, potentially leading to improper fracture alignment.
Patients who received this specific hip fracture nail model during surgery are affected. Surgeons and medical staff using the product are most at risk of improper fixation.
Check for the product name 'Affixus Hip Fracture Nail Left 130', size 11mm x 400mm, and item number 814611400. The product was sold with specific serial numbers listed in the recall notice.
Identify the product name, size, and item number to confirm if it matches the recalled model.
The recall indicates a potential issue with the set screw, which could lead to improper bone fixation. However, the specific hazard does not mention immediate injury risk in normal use.
Look for the product name 'Affixus Hip Fracture Nail Left 130', size 11mm x 400mm, and item number 814611400. The product was sold with specific serial numbers listed in the recall notice.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance on next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3159-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3159-2018 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.
