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 nail might not stabilize the fracture properly during surgery, potentially leading to improper healing or complications.
Surgeons who use the Affixus Hip Fracture Nail System (model 814411300) for hip fracture repairs are affected. The risk is highest for procedures involving unstable fractures.
Check for the model number 814411300 on the nail packaging or label. The product was sold with lot numbers 133240 and 971270.
Look for the model number 814411300 on the nail packaging or label.
The set screw cannot advance or reverse from the original position, which may cause improper fracture stabilization during surgery.
The recall record does not specify a remedy, so no action is required beyond checking if you have the model number 814411300.
The recall indicates a potential risk for improper fracture stabilization during surgery, but the record does not specify patient injury reports.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0448-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0448-2019 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.
