Zimmer Biomet recalls left hip fracture nails with set screw issues that may not advance or reverse properly. Affected models include 130mm x 280mm, item 814:613280. No remedy specified in recall notice.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling left hip fracture nails that have a set screw which may not advance or reverse properly. This could lead to improper fixation of the hip fracture, potentially causing complications during surgery or recovery.
The set screw in the nail may not advance or reverse from its original position, which could prevent proper fixation of the hip fracture. This might cause the nail to become loose or dislodged during surgery or after the procedure, leading to complications.
Surgical patients who received the recalled left hip fracture nails during procedures between 2020 and 2023 are affected. Surgeons and medical staff using these specific nails for hip fracture repairs are most at risk.
Check for the product name 'Affixus Hip Fracture Nail Left 130' with dimensions 13 mm x 280 mm. The item number 814613280 is also associated with this recall.
Reach out to Zimmer Biomet directly to confirm if your specific nail is affected and get guidance on next steps.
The recall notice does not specify any remedy for the set screw problem.
Look for the product name 'Affixus Hip Fracture Nail Left 130' with dimensions 13 mm x 280 mm and item number 814613280.
The recall notice does not state a specific issue date or timeframe for when the product was sold.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3164-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3164-2018 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.