Zimmer Biomet recalls Affixus Hip Fracture Nail Right 125 model due to set screw not advancing or reversing properly. Affected units may cause 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 move forward or backward as intended. This could lead to improper bone fixation during surgery.
The set screw in the nail fails to advance or reverse from its original position. This means the nail may not secure bones properly during surgery, potentially leading to improper healing.
Surgical teams using the Affixus Hip Fracture Nail Right 125 model for hip fracture repairs are affected. Patients undergoing surgery with this specific nail are at risk of improper fixation.
Check for the Affixus Hip Fracture Nail Right 125 model with 13 mm x 300 mm dimensions and item number 814313300. The recall covers 645,720 units sold.
Identify the model, size, and item number to confirm if your nail is affected.
The recall is for a potential issue with the set screw not advancing or reversing, which could lead to improper bone fixation during surgery. However, the hazard level is low risk as the remedy is not specified.
Check for the Affixus Hip Fracture Nail Right 125 model with 13 mm x 300 mm dimensions and item number 814313300. The recall covers 645,720 units.
The recall does not specify a remedy, so no action is required unless you have the affected model. Contact Zimmer Biomet 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-3069-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3069-2018 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.
