Zimmer issued a recall for 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized diameter, risking fatigue fractures. This defect could lead to severe health complications for patients.
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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This recall affects the Affixus Antegrade Femoral Nails, model number 815509440. The product is 9 mm in diameter and 440 mm in length. The affected implants were distributed nationwide in various states.
The affected implants may have an undersized distal diameter, which could lead to implant fatigue fracture. Potential health risks include adverse local tissue reactions, chronic pain, non-union or malunion of bones, and tissue damage requiring surgery.
As of now, no specific incidents or injuries have been reported. The recall indicates a high risk of complications should a fatigue fracture occur.
Patients and healthcare providers should stop using the device immediately. Contact Zimmer, Inc. or your healthcare provider for further instructions on the recall.
For more information, contact Zimmer, Inc. at their official website or call their customer service.
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