Zimmer Biomet recalls Affixus Hip Fracture Nail Left 130mm 9mm x 400mm (Item 814609400) due to set screw malfunction. This may cause improper fixation during hip fracture repair. Affected patients should contact the manufacturer for details.
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 properly advance or reverse. This could lead to improper bone fixation during surgery, potentially causing complications after hip fracture repair.
The set screw in this hip fracture 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 bone fixation and potential complications after hip fracture repair.
Patients who received this specific hip fracture nail model (left side, 130mm, 9mm x 400mm) from Zimmer Biomet. Surgeons and medical staff using this product for hip fracture repairs are most at risk.
Check if your hip fracture nail has the model name 'Affixus', size 130mm, 9mm x 400mm, and item number 814609400. This product was sold under the item numbers listed in the recall notice.
Reach out to Zimmer Biomet directly for specific instructions on how to handle the recalled product.
The recall states the set screw may not advance or reverse properly, which could lead to improper bone fixation during hip fracture repair. However, the hazard level is low risk as the remedy does not require immediate stop-use.
Check for the model name 'Affixus', size 130mm, 9mm x 400mm, and item number 814609400. This product was sold with specific item numbers listed in the recall notice.
Contact Zimmer Biomet directly for specific instructions on handling the recalled product. The recall does not specify a return or replacement process.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3150-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3150-2018 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.
