Zimmer Biomet recalls Affixus Hip Fracture Nail Left 125 (13mm x 340mm) due to set screw not advancing or reversing properly. Affected units may need replacement.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling Affix: Hip Fracture Nail Left 125 models because the set screw can't move properly. This could lead to improper fixation of the hip fracture, risking complications during healing.
The set screw in the nail cannot advance or reverse from its original position. This means the nail may not stay securely in place, potentially causing the implant to shift during healing or movement.
Patients who have received the Affixus Hip Fracture Nail Left 125 (13mm x 340mm) implant are affected. Surgeons and medical staff who used this model during procedures are also at risk.
Check for the model name 'Affixus Hip Fracture Nail Left 125' with dimensions 13 mm x 340 mm. The item number 814413340 is also associated with this recall.
Verify the model name, dimensions, and item number to confirm if your product is affected.
The recall is for a potential issue with the set screw not advancing or reversing properly, which could affect implant stability. However, the hazard level is low risk as the remedy is not specified and the issue may not cause serious injury in normal use.
Check for the model name 'Affixus Hip Fracture Nail Left 125' with dimensions 13 mm x 340 mm and item number 814413340.
The recall does not specify a remedy, so no action is required. However, you should check with your healthcare provider if you have concerns about the implant's stability.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3102-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3102-2018 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.
