Zimmer Biomet recalls Affixus Hip Fract: Set screw cannot advance or reverse, potentially causing improper fracture stabilization.
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 improper fracture stabilization during surgery, risking complications for patients.
The set screw in the nail cannot advance or reverse from its original position. This means the nail may not stabilize the hip fracture correctly during surgery, potentially leading to complications.
Surgeons who use the Affixus Hip Fracture Nail System (item number 816712165) for hip fracture repairs are affected. Patients undergoing surgery with this specific nail system are at risk of improper stabilization.
Check for the Affixus Hip Fracture Nail System with item number 816712165. Lot numbers 145060, 901680, and 901690 are also associated with this recall.
Verify the item number and lot numbers to confirm if your nail system is affected.
The set screw cannot advance or reverse from the original position in the nail, which may lead to improper fracture stabilization during surgery.
Check for item number 816712165 and lot numbers 145060, 901680, or 901690.
The recall does not specify a remedy, so contact Zimmer Biomet directly for further instructions.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0452-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0452-2019 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.
