Zimmer Inc. recalled 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have undersized distal diameters, risking implant fatigue fractures. Consumers 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 Affixus Antegrade Femoral Nails are orthopedic implants used for stabilizing femur fractures. Surgeons typically use these devices in procedures to repair complex fractures in the femur.
The undersized distal diameter along the shaft increases the risk of fatigue fractures, which can compromise the integrity of the implant and lead to further complications.
This recall is not part of a broader industry pattern.
This recall poses significant health risks to patients requiring surgical intervention if fractures occur, leading to potential pain and complications.
The model and lot numbers are typically found on the packaging or the device itself.
Expect a response regarding refunds or replacements within 4-6 weeks.
Keep records of all communications with the manufacturer, including emails and letters regarding the recall.
The recall affects 22 units of Affixus Antegrade Femoral Nails, Model 815509320. These were distributed nationwide in states including California and Florida. The implants are 9 mm in diameter and 320 mm in length.
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