Zimmer recalled 11 Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may fracture, leading to serious health risks. Patients 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 involves Affixus Antegrade Femoral Nails, Model No 815609300. The product is 9 mm in diameter and 300 mm in length. The affected units were distributed in several states across the U.S.
The femoral nails may have an undersized distal diameter, increasing the risk of implant fatigue fracture. This can lead to severe complications including adverse tissue reactions and the need for additional surgeries.
There are no specific incident counts reported, but potential risks include pain, tissue damage, and surgical interventions due to implant failure.
Patients and healthcare providers should immediately stop using the affected devices. Contact Zimmer, Inc. or your healthcare provider for further instructions.
For more information, visit the FDA recall page at the provided URL. Alternatively, contact Zimmer, Inc. directly.
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