Zimmer Inc. recalled 24 units of Affixus Antegrade Femoral Nails on December 2, 2025. The recall follows reports of undersized distal diameters that could lead to implant fatigue fractures. This defect poses a high risk of adverse tissue reactions and requires immediate action.
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 recalled product is the Affixus Antegrade Femoral Nail, model number 815609400. It consists of a 9 mm diameter and 400 mm length nail. Sold nationwide in various states, it is part of Zimmer's medical device lineup.
Affected implants may have an undersized distal diameter along the shaft, leading to implant fatigue fractures. This condition can result in serious health risks including pain, tissue damage, and the need for surgical intervention.
There are no specific incident reports or injuries disclosed. However, potential risks include adverse local tissue reactions and complications such as non-union or malunion.
Patients and healthcare providers should stop using the affected devices immediately. Follow the recall instructions provided by Zimmer Inc. and contact your healthcare provider for further guidance.
For further assistance, contact Zimmer Inc. directly. Visit their website or call their customer service for detailed instructions regarding the recall.
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