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 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.
Affected implants may experience fatigue fractures due to an undersized distal diameter. If a fracture occurs, it can cause adverse local tissue reactions, pain, and complications such as non-union or malunion.
As of the current report, there are no specific incidents of injury or fracture documented. However, the potential for serious health impacts necessitates immediate action.
Stop using the affected implants immediately. Contact Zimmer, Inc. or your healthcare provider for specific instructions on handling the recall.
For more information, contact Zimmer, Inc. at their official website or customer service line. Additional details can also be found at the FDA recall website.
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