Zimmer Biomet recalls Affixus Hip Fracture Nail Right 130 (9mm x 420mm) due to set screw not advancing or reversing properly. Affected units may need repair or replacement.
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 its set screw can't move correctly. This could lead to improper fixation of the hip fracture, risking complications during healing.
The set screw in the nail cannot advance or reverse from its original position. This means the nail might not stay securely in place during surgery, potentially causing the fracture to shift or fail to heal properly.
Orthopedic surgeons and medical professionals using the Affixus Hip Fracture Nail Right 130 model for hip fracture repairs. Those at highest risk are surgeons handling the specific item number.
Check for the model name 'Affixus Hip Fracture Nail Right 130' with dimensions 9 mm x 420 mm. The item number 814509420 is also associated with this recall.
Verify the item number on the product is 814509420 to confirm if it's affected.
The recall states the set screw may not advance or reverse properly, which could affect surgical fixation. However, the official notice does not specify if the product is safe when used correctly.
Look for the model name 'Affixus Hip Fracture Nail Right 130' with dimensions 9 mm x 420 mm and item number 814509420.
The recall record does not specify a remedy, so the official notice does not state what action to take.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3117-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3117-2018 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.