Zimmer Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, leading to potential health risks. Patients should stop using the devices 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 affects Affixus Antegrade Femoral Nails, Model No 815509380. The product was distributed nationwide in the United States, including states such as California and Texas.
The implants may have an undersized distal diameter along the shaft, leading to implant fatigue fractures. This risk can cause adverse local tissue reactions, pain, non-union or malunion, and tissue damage requiring surgical intervention.
There are no specific incident counts reported as of now, but the potential risks involve severe complications requiring further medical procedures.
Stop using the affected devices immediately. Contact Zimmer Inc. or your healthcare provider for further instructions and guidance on the recall.
For more information, contact Zimmer Inc. through their website or customer service hotline. Additional details can also be found on the FDA website.
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