Zimmer Biomet recalls specific hip fracture nail models due to set screw not advancing or reversing properly, which could affect surgical 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 doesn't work correctly. This could lead to improper surgical fixation, potentially causing complications after hip fracture repair.
The set screw in the nail cannot move forward or backward from its starting position. This may prevent the nail from securely fixing the bone fragments during surgery, potentially leading to complications.
Surgical patients who received the recalled hip fracture nail model during procedures. Patients using the nail for hip fracture repair are most at risk.
Check for the model name 'Affixus Hip Fracture Nail Left 125', size 11 mm x 260 mm, and item number 814411260. The product was sold under the item number 503640.
Identify if your hip fracture nail matches the model name, size, and item number listed in the recall.
The recall states the set screw may not advance or reverse properly, which could affect surgical fixation. However, the hazard level is low risk as the remedy does not require immediate stop-use.
Look for the model name 'Affixus Hip Fracture Nail Left 125', size 11 mm x 260 mm, and item number 814411260. The product was sold under item number 503640.
The recall does not specify a remedy, so you should check with your surgeon or healthcare provider to determine if the product needs attention.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3089-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3089-2018 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.
