Zimmer Inc. recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have undersized distal diameters, leading to potential fractures. Users should stop using the product 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 recall involves Affixus Antegrade Femoral Nails, Model Number 815609380. The product was distributed nationwide across several states including California, Texas, and Florida. This model does not have a listed price.
The recalled implants may have an undersized distal diameter along the shaft. This defect could lead to implant fatigue fractures, resulting in serious health risks including tissue damage and the need for surgical intervention.
No specific incidents have been reported in connection with the recalled implants. However, the potential risks include adverse local tissue reactions and pain.
Stop using the affected device immediately. Follow the manufacturer’s recall instructions and contact Zimmer, Inc. or your healthcare provider for further guidance.
For further assistance, contact Zimmer, Inc. via their website or customer service hotline. Additional recall details are available at the FDA's enforcement report page.
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