Zimmer Biomet recalls Affixus Hip Fracture Nail Left 130 (11mm x 340mm) due to set screw not advancing or reversing. Affected items have specific item numbers and were sold in certain quantities.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling Affixus Hip Fracture Nail Left 130 models because the set screw cannot properly advance or reverse. This could lead to improper fixation during hip fracture treatment, potentially causing complications.
The set screw in the nail cannot advance or reverse from its original position. This may result in the nail not being properly secured to the bone, which could cause the implant to shift or fail during healing.
Orthopedic surgeons and medical facilities using the Affixus Hip Fracture Nail Left 130 models are likely affected. Patients receiving this specific implant are at risk if the set screw malfunctions during surgery.
Check for the item number 814611340 on the Affixus Hip Fract: 130 (11mm x 340mm) model. The product was sold in specific quantities identified by the numbers 154800 through 944920.
Verify the item number on the product is 814611340.
The recall indicates a potential issue with the set screw, but the product is not safe for use as described in the recall.
The recall does not specify a remedy, so contact Zimmer Biomet directly for further instructions.
Look for the item number 814611340 on the Affixus Hip Fracture Nail Left 130 (11mm x 340mm) model.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3156-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3156-2018 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.
