Zimmer, Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, risking implant fatigue fracture. This defect can cause severe health issues, including pain and tissue damage requiring surgery.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Zimmer, Inc. or your healthcare provider for instructions. Notification method: Letter
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The Affixus Antegrade Femoral Nails are used in orthopedic surgery for stabilizing fractures in the femur. Surgeons choose this product for its design and compatibility with various surgical techniques.
The hazard arises from the potential for an undersized distal diameter, which can lead to fractures of the implant under stress. Such fractures pose serious health risks, including the need for additional surgeries.
This recall is not part of a broader industry pattern.
Patients with the affected implants may face significant health risks and potential surgical interventions if not addressed promptly.
Model and lot numbers are usually engraved on the implant or available in your medical records.
Expect a refund or replacement within 4-6 weeks after contacting Zimmer, Inc.
Keep records of your implant details, any symptoms experienced, and correspondence with the manufacturer.
The recalled product is the Affixus Antegrade Femoral Nails, Model/Catalog Number 815609320. The implants were distributed nationwide across several states including California and Texas. They are not priced in the recall data.
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