Zimmer Biomet recalls Affixus Hip Fracture Nails with set screw that cannot advance or reverse, potentially causing improper fracture stabilization 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 won't move properly. This could lead to unstable fracture fixation during surgery, risking improper healing.
The set screw in the nail cannot advance or reverse from its original position. This means the surgeon may not be able to properly secure the nail in place during hip fracture surgery, potentially leading to unstable fixation and improper healing.
Surgeons who use the Affixus Hip Fracture Nail System (specifically the Left 130 Deg 11x300mm model) are affected. Patients undergoing hip fracture surgery with this system face the highest risk.
Check for the product name 'Affixus Hip Fracture Nail Left 130 Deg 11x300mm' with item number 814611300. The lot numbers 157410 to 171840 are also associated with this recall.
Verify the item number 814611300 and lot numbers 157410 to 171840 on the product packaging.
The set screw in the Affixus Hip Fracture Nail cannot advance or reverse from its original position, which may lead to improper fracture stabilization during surgery.
The recall record does not specify a remedy, so there is no action required beyond checking if your product matches the description.
The recall indicates a potential issue with surgical fixation, but the record does not specify if this could cause serious injury in normal use.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0449-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0449-2019 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.
