Affixus recalled 22 units of its antegrade femoral nailing system on December 2, 2025, due to a risk of implant fatigue fracture. The defect may lead to serious health complications including tissue damage and pain. Consumers and healthcare providers must stop using the affected implants immediately.
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 recall involves the Affixus Antegrade Femoral Nails, model number 815509420. These implants were distributed nationwide in various states, including California and Texas. There is no price mentioned for the product.
Affected implants may have an undersized distal diameter along the shaft, leading to fatigue fractures. A fracture poses serious health risks, including adverse local tissue reactions, pain, and potential surgical interventions.
There are no specific reported incidents of injury or death associated with this recall. However, potential risks include pain, non-union or malunion, or tissue damage.
Patients and healthcare providers should immediately stop using this device. Follow the recall instructions from the manufacturer and contact Zimmer, Inc. for further guidance.
For more information, visit Zimmer's website or call their customer service. Additional recall details can be found at the FDA website.
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