Affixus recalled its Antegrade Femoral Nailing System on December 2, 2025, due to a potential implant fatigue fracture risk. The recall affects 22 units distributed nationwide in 14 states. Patients should stop using the affected devices immediately to avoid serious health risks.
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 Affixus Antegrade Femoral Nailing System is used to stabilize femur fractures. It is designed for patients requiring surgical intervention for bone stabilization.
Implants may have an undersized distal diameter, risking fatigue fractures that can lead to severe complications.
This recall is not part of a broader industry pattern.
Patients may face health risks that could require further surgeries, leading to additional medical costs and recovery time.
You can typically find the model number and lot number on the packaging or the device itself.
Expect a refund or replacement process to take approximately 4 to 6 weeks.
Keep any receipts, correspondence about the recall, and photographs of the implant for your records.
The recall includes Affixus Antegrade Femoral Nails, specifically model number 815509340. The affected implants feature a distal diameter that may be undersized along the shaft. These devices were distributed across various states including Texas, California, and Florida.
Not sure what to do next? Our guide walks you through the process step by step.
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