Zimmer Biomet recalls hip fracture nails with set screw that won't advance or reverse, potentially causing improper fixation. Affected models include left 130mm 9mm x 320mm nails with item number 814609320.
The set screw is not able to advance or reverse from the original position in the nail.
Zimmer Biomet is recalling hip fracture nails that have a set screw which won't advance or reverse properly. This could lead to improper bone fixation during surgery, risking complications for patients needing hip fracture repair.
The set screw in the nail cannot move forward or backward from its starting position. This prevents the nail from being properly secured in the bone, which could cause the nail to shift during healing or surgery.
Surgical patients who received the recalled hip fracture nail during procedures. Orthopedic surgeons and hospitals using this specific model are most at risk of improper fixation.
Check if your hip fracture nail is labeled as 'Left 130mm 9mm x 320mm' with item number 814609320. The product was sold under the Affixus brand for hip fracture repairs.
Look for the model description 'Left 130mm 9mm x 320mm' and item number 814609320 on the nail packaging or device.
The recall states the set screw may not advance or reverse properly, which could lead to improper bone fixation. However, the remedy is not specified, so the risk level is low.
Check if your hip fracture nail is labeled as 'Left 130mm 9mm x 320mm' with item number 814609320.
The recall does not specify a remedy, so no action is required. Contact Zimmer Biomet directly if you have concerns.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3148-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3148-2018 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.
