Zimmer Biomet recalls Affixus Hip Fracture Nail Left 125mm (Item 81441: 11mm x 420mm) due to set screw malfunction. Affected units may not advance or reverse properly, potentially causing improper fixation.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling Affixus Hip Fracture Nails (Left 125mm) because the set screw may not advance or reverse correctly. This could lead to improper hip fracture fixation, risking complications during surgery or recovery.
The set screw in the nail may not move forward or backward from its starting position. This could prevent the nail from securing the bone fragments correctly, potentially causing the fracture to shift or fail during healing.
Surgical patients who received the recalled Affixus Hip Fracture Nail Left 125mm (11mm x 420mm) during surgery. Patients using the product post-surgery are at risk if the nail fails to function properly.
Check for the product name 'Affixus Hip Fracture Nail Left 125mm' with dimensions 11mm x 420mm. The item number is 814411420. Units sold between 2020-2023 (based on serial numbers 155120 to 813860).
Verify the product name, dimensions, and item number to confirm if your nail is affected.
The recall indicates the set screw may not function properly, but the product is safe if used as intended by a qualified surgeon.
Look for the product name 'Affixus Hip Fracture Nail Left 125mm' with dimensions 11mm x 420mm and item number 814411420.
No action is required if the product was used correctly by a surgeon. The recall is for specific units that may not function properly.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3095-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3095-2018 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.
