Zimmer Biomet recalls Affixus Hip Fracture Nail Left 125 (11mm x 400mm) 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 a specific hip fracture nail model because the set screw cannot move correctly. This could lead to improper bone fixation and potential complications after surgery.
The set screw in the nail cannot advance or reverse from its original position. This may cause the nail to become improperly fixed in the bone, potentially leading to complications during healing or future surgeries.
Surgical patients who received this specific hip fracture nail model during procedures. Patients using the product post-surgery are most at risk if the set screw fails.
Check for the model name 'Affixus Hip Fracture Nail Left 125' with dimensions 11 mm x 400 mm. The item number 814411400 is also associated with this recall.
Verify the model number and dimensions to confirm if the product is affected.
The recall states the set screw may not advance or reverse properly, but it does not specify that the product is dangerous if used correctly.
Look for the model name 'Affixus Hip Fracture Nail Left 125' with dimensions 11 mm x 400 mm and item number 814411400.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3094-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3094-2018 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.
