Zimmer, Inc. recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. These implants may have an undersized distal diameter that could lead to fatigue fractures. Patients should stop using the device immediately and contact their healthcare provider.
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 in orthopedic procedures to stabilize fractured femurs. They are commonly used in surgeries to assist with bone healing and alignment.
The undersized distal diameter of the nails can lead to structural weaknesses. This may cause the implant to fracture under normal stress, resulting in significant health risks for the patient.
This recall is not part of a broader industry pattern.
Patients using this implant face potential surgical risks and complications. Immediate action is necessary to avoid serious health consequences.
Model numbers and lot numbers are usually found on the device packaging or in your medical records.
Expect a refund or replacement within 4 to 6 weeks after submitting your request.
Keep all correspondence regarding the recall, including letters from the manufacturer and any medical records related to your implant.
The recall involves the Affixus Antegrade Femoral Nails, Model 815509400, with a 9 mm diameter and 400 mm length. These products were distributed nationwide in the U.S., including states such as California and Texas.
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