Zimmer issued a recall for 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized diameter, risking fatigue fractures. This defect could lead to severe health complications for patients.
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 medical devices used for the stabilization of fractures in the femur. Surgeons typically use them in orthopedic procedures to ensure proper alignment and healing of bone fractures.
The defect in the distal diameter of the implants can lead to fatigue fractures, which may compromise the stability of the bone and lead to further complications.
This recall is not part of a broader industry pattern.
Patients using the affected implants face serious health risks, including the potential need for additional surgeries to address complications.
You can find the model number and lot codes on your surgical records or the device packaging if available.
Expect a timeline of 4-6 weeks for refund processing or further instructions from the manufacturer.
Keep all records related to your implant, including surgical notes, correspondence regarding the recall, and any symptoms experienced.
This recall affects the Affixus Antegrade Femoral Nails, model number 815509440. The product is 9 mm in diameter and 440 mm in length. The affected implants were distributed nationwide in various states.
Not sure what to do next? Our guide walks you through the process step by step.
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