Zimmer recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, leading to potential fatigue fractures. Health risks include pain, tissue damage, and the need for surgical intervention.
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 Nailing System is used in orthopedic surgeries for stabilizing fractures in the femur. It is commonly utilized in procedures related to trauma or orthopedic conditions requiring internal fixation.
The hazard arises from an undersized distal diameter in the implants, which increases the risk of fatigue fractures during use. Such fractures can lead to significant complications requiring additional surgical intervention.
This recall is not part of a broader industry pattern.
Consumers using the affected implants face serious health risks, including pain and the potential need for surgical repair, which can lead to significant healthcare costs and recovery time.
Model numbers and lot codes can typically be found on the device packaging or accompanying documentation.
Expect a timeline of 4-6 weeks for processing refunds or replacements for affected devices.
Document all correspondence related to the recall, including emails and phone call records. Keep any medical documentation related to the use of the device.
The recall involves Affixus Antegrade Femoral Nails, model number 815609420, with a diameter of 9 mm and a length of 420 mm. The affected products were distributed nationwide across multiple states.
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