Zimmer Biomet recalls Affixus Hip Fracture Nail Right 125 model due to set screw not advancing or reversing properly. Affected units may need repair or 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 the nail from properly securing the bone, risking improper healing.
The set screw in the nail is designed to be tightened or loosened during surgery. If it cannot advance or reverse from its starting position, the nail may not secure the bone properly, potentially leading to improper healing or complications.
Orthopedic surgeons and medical professionals who use this specific hip fracture nail model during surgery are affected. Patients receiving this implant are at risk of improper healing due to the malfunction.
Check for the model name 'Affixus Hip Fracture Nail Right 125' with dimensions 13 mm x 440 mm and item number 814:313440. The product was sold in the U.S. between 2019 and 2020.
Verify the model name, dimensions, and item number to confirm if your nail is affected.
The set screw may not advance or reverse properly, which could lead to improper bone fixation. However, the risk is low for most surgical procedures.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance.
The product was sold in the U.S. between 2019 and 2020.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3076-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3076-2018 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.