Zimmer Biomet recalls Affixus Hip Fracture Nail Right 130 model due to set screw not advancing or reversing properly. Affected units may require 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 cannot move forward or backward as intended. This could prevent proper fixation of the hip fracture, potentially leading to complications during healing.
The set screw in the nail is designed to advance or reverse from its original position to secure the implant. If it cannot move, the nail may not hold properly, risking improper healing or the need for additional surgery.
Orthopedic surgeons and medical professionals who use this specific hip fracture nail model are affected. Patients receiving this implant during surgery are at risk if the set screw fails to function correctly.
Check for the model name 'Affixus Hip Fracture Nail Right 130', size 13 mm x .280 mm, and item number 814513280. The product was sold under the item numbers 213010, 707970, and 944730.
Verify the model name, size, and item number to confirm if your product is affected.
The recall does not specify if patients who have already had surgery are affected. This recall applies to the product before use.
The recall record does not provide a remedy, so no specific action is required beyond checking if your product matches the description.
Check for the model name 'Affixus Hip Fracture Nail Right 130', size 13 mm x 280 mm, and item number 814513280.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3134-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3134-2018 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.
