Zimmer Biomet recalls Affix: Hip Fracture Nail 130 Deg 12x165mm (Item 816812165) due to set screw not advancing or reversing properly. Affected units may cause 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 cannot advance or reverse from its original position. This could lead to improper fracture stabilization during surgery, potentially causing complications for patients.
The set screw in the nail cannot move forward or backward from its starting position. This may prevent the nail from properly securing the fracture site, leading to instability during healing.
Surgeons who use the Affixus Hip Fracture Nail System (Item 816812165) for hip fracture repairs are affected. Patients receiving this specific nail system during surgery are at risk of improper stabilization.
Check for the Affixus Hip Fracture Nail 130 Deg 12x165mm with Item Number 816812165. The lot number 901770 is associated with this recall.
Verify the item number and lot number on the nail system to confirm if it is affected.
The recall is for a potential issue with the set screw not advancing or reversing, which could lead to improper fracture stabilization. However, the hazard is not described as causing serious injury in normal use.
The recall record does not specify a remedy, so no action is required at this time. Check the product details to confirm if it is affected.
Look for the Affixus Hip Fracture Nail 130 Deg 12x165mm with Item Number 816812165 and Lot Number 901770.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0454-2019 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0454-2019 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.
