Zimmer Biomet recalls Affixus Hip Fracture Nail Left 130 (11mm x 380mm) due to set screw not advancing or reversing properly. Affected units may cause 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 Fract: 130 Left 11mm x 380mm nails because the set screw cannot move correctly. This could lead to improper hip fracture fixation and potential complications.
The set screw in the nail fails to advance or reverse from its original position. This means the nail may not secure properly during surgery, potentially leading to improper fixation of the hip fracture.
Orthopedic surgeons and medical professionals using the Affixus Hip Fracture Nail Left 130 (11mm x 380mm) for hip fracture repairs. Those at highest risk are practitioners who have recently used this specific model.
Check for the Affixus Hip Fracture Nail Left 130 (11mm x 380mm) with item number 814611380. The product was sold under specific model codes including 152900 through 901600.
Verify the item number and model codes listed in the recall notice to confirm if your product is affected.
The recall indicates a potential issue with the set screw, so it is not recommended for use until the remedy is applied.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance on next steps.
Check for the Affixus Hip Fracture Nail Left 130 (11mm x 380mm) with item number 814611380 or model codes 152900 through 901600.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3158-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3158-2018 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.
