Zimmer, Inc. recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. These implants may have an undersized distal diameter that could lead to fatigue fractures. Patients should stop using the device 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 the Affixus Antegrade Femoral Nails, Model 815509400, with a 9 mm diameter and 400 mm length. These products were distributed nationwide in the U.S., including states such as California and Texas.
Affected implants may have an undersized distal diameter along the length of the shaft, leading to a risk of fatigue fractures. This could result in adverse local tissue reactions, pain, non-union or malunion, and potential surgical intervention.
There have been no reported injuries or deaths associated with this recall. However, risks include significant health complications that could necessitate further medical procedures.
Patients and healthcare providers should stop using the affected devices immediately. Contact Zimmer, Inc. or a healthcare provider for further instructions and follow recall instructions.
For further inquiries or to report issues, contact Zimmer, Inc. at www.zimmer.com or through their customer service hotline.
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