Zimmer Biomet recalls specific hip fracture nail models due to set screw malfunction. Affected items 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 certain hip fracture nail models because the set screw can't properly advance or reverse. This could lead to improper bone fixation and increased risk of complications after surgery.
The set screw in the nail fails to move forward or backward from its starting position. This prevents the nail from securely anchoring to the bone, which could cause the implant to loosen or shift during healing.
Surgical patients who received the specific hip fracture nail model (125mm, 13mm x 320mm) from Zimmer Biomet. Patients who had the implant placed during the specified time frame are most at risk.
Check for the model name 'Affixus Hip Fracture Nail Left 125mm' with dimensions 13mm x 320mm and item number 814413320. The product was sold with specific part numbers 245830 and 331620.
Verify the model name, dimensions, and item number to confirm if your nail is affected.
The set screw cannot advance or reverse from the original position in the nail, which may lead to improper bone fixation.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance.
The recall indicates a potential issue with bone fixation, but no specific injury mechanism is described.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3101-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3101-2018 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.