Zimmer Biomet recalls specific hip fracture nail models due to set screw not advancing or reversing properly. Affected items may not function correctly during surgery.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling hip fracture nails that have a set screw which cannot advance or reverse from its original position. This could lead to improper fixation during surgery if the nail is used.
The set screw in the nail cannot move forward or backward from its starting position. This may prevent the nail from being properly secured during surgery, potentially leading to inadequate fracture fixation.
Surgical teams using the specific Affixus Hip Fracture Nail Right 130 model are affected. Patients undergoing hip fracture surgery with this nail are at risk of improper fixation.
Check for the model name 'Affixus Hip Fracture Nail Right 130' with dimensions 9 mm x 260 mm. The item number 814509260 or 813650 is also associated with this recall.
Verify the model name, dimensions, and item number to confirm if your nail is affected.
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 is not specified and the issue may not cause serious injury in normal use.
The recall record does not specify a remedy, so no action is required unless you are using the product in surgery.
Check for the model name 'Affixus Hip Fracture Nail Right 130' with dimensions 9 mm x 260 mm and item numbers 814509260 or 813650.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3109-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3109-2018 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.
