Zimmer Biomet recalls specific hip fracture nail models due to set screw malfunction. Affected items may not advance or reverse properly, requiring immediate action.
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 move properly. This could lead to improper fixation of the hip fracture, risking complications during healing.
The set screw in the nail fails to advance or reverse from its original position. This means the nail may not stay securely in place during surgery, potentially causing improper fixation of the hip fracture site.
Orthopedic surgeons and medical professionals using the Affixus Hip Fracture Nail Left 125 model for hip fracture repairs. Those at highest risk are practitioners who have recently used this specific product.
Check for the model name 'Affixus Hip Fracture Nail Left 125' with dimensions 13 mm x 380 mm and item number 814:413380. The product was sold in specific batches identified by the numbers 417480 and 646660.
Verify the model name, dimensions, and item number to confirm if your product is affected.
The recall states the set screw may not advance or reverse properly, which could lead to improper fixation. However, the product is not inherently dangerous if used correctly with the intended procedure.
The recall does not specify a remedy, so you should check with Zimmer Biomet directly for guidance on next steps.
Look for the model name 'Affixus Hip Fracture Nail Left 125', dimensions 13 mm x 380 mm, and item number 814413380. The product was sold in specific batches identified by the numbers 417480 and 646660.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3104-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3104-2018 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.
