Zimmer Biomet recalls Affixus Hip Fracture Nail Right 125mm 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 its set screw doesn't work correctly. This could prevent the nail from being properly secured, potentially causing injury during surgery.
The set screw in the nail cannot move forward or backward from its starting position. This means the nail might not stay securely in place during surgery, which could lead to improper healing or complications.
Surgical teams using the Affixus Hip Fracture Nail Right 125mm model (item number 814309420) for hip fracture repairs are affected. Patients undergoing surgery with this specific implant are at risk.
Check for the model name 'Affixus Hip Fracture Nail Right 125mm' and item number 814309420. The product was sold in specific quantities with the item number listed in the recall notice.
Verify the model name and item number to confirm if your nail is affected.
The recall indicates a potential issue with the set screw not advancing or reversing properly, which could affect surgical security. However, the hazard is described as low risk in this recall.
The recall does not specify a remedy, so you should check with Zimmer Biomet directly for guidance.
Look for the model name 'Affixus Hip Fracture Nail Right 125mm' and item number 814309420.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3052-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3052-2018 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.