Zimmer Biomet recalls Affixus Hip Fracture Nail Right 130 (13mm x 300mm) 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 after surgery, potentially causing the hip fracture to shift or not heal properly.
Patients who received the Affixus Hip Fracture Nail Right 130 (13mm x 300mm) with item number 814513300 are affected. Surgeons and medical staff using this model during procedures are most at risk.
Check for the product name 'Affixus Hip Fracture Nail Right 130' with dimensions 13 mm x 300 mm. The item number 814513300 is also listed on the packaging.
Verify the product name, dimensions, and item number on the packaging to confirm if it matches the recalled model.
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.
The recall record does not mention any remedy or replacement process.
The recall record does not provide specific action steps beyond checking product details.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-3135-2018 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-3135-2018 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.