Zimmer Inc. recalled 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have undersized distal diameters, risking implant fatigue fractures. Consumers should stop using the device immediately and follow manufacturer instructions.
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 22 units of Affixus Antegrade Femoral Nails, Model 815509320. These were distributed nationwide in states including California and Florida. The implants are 9 mm in diameter and 320 mm in length.
The undersized distal diameter may lead to implant fatigue fractures. Potential health risks include adverse tissue reactions, pain, non-union or malunion, and possible tissue damage requiring surgical intervention.
No specific incidents have been reported at this time. The recall was issued as a precaution due to potential risks associated with the product.
Patients and healthcare providers should stop using the affected devices immediately. Contact Zimmer, Inc. or your healthcare provider for further instructions regarding the recall.
For more information, contact Zimmer, Inc. directly. Visit their website or call customer service for guidance on the recall.
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