Zimmer Biomet recalls Affixus Hip Fracture Nail Left 130 (13mm x 300mm) due to set screw not advancing or reversing properly. Affected units may need repair or replacement.
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 (13mm x 300mm) because the set screw cannot advance or reverse from its original position. This could lead to improper fixation of the hip fracture nail, potentially causing complications during surgery or after implantation.
The set screw in the nail cannot move forward or backward from its starting position. This may prevent the nail from being properly secured to the bone, which could lead to the implant becoming loose or shifting during healing.
Surgical patients who received this specific hip fracture nail implant during procedures between 2021 and 2023 are affected. Patients who have the implant are most at risk.
Check for the product name 'Affixus Hip Fracture Nail Left 130' with dimensions 13mm x 300mm and item number 814613300 or 818430 960660. The recall applies to units sold between 2021 and 2023.
Verify the item number and dimensions to confirm if your nail is affected.
The recall states the set screw may not advance or reverse properly, which could lead to improper fixation. However, the hazard is described as low risk as it does not cause immediate injury in normal use.
Check for the product name 'Affixus Hip Fracture Nail Left 130' with dimensions 13mm x 300mm and item numbers 814613300 or 818430 960660.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance on next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3165-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3165-2018 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.