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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Zimmer, Inc. recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. These implants may have an undersized distal diameter that could lead to fatigue fractures. Patients should stop using the device immediately and contact their healthcare provider.
Zimmer Inc. recalled 24 units of the Affixus Antegrade Femoral Nailing System on December 2, 2025. Affected implants may have an undersized distal diameter that could lead to implant fatigue fractures. Risks include pain, tissue damage, and potential surgical intervention.
Zimmer, Inc. recalled 11 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, posing a risk of fatigue fracture. This defect could cause adverse reactions requiring surgical intervention.
Zimmer recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, leading to potential fatigue fractures. Health risks include pain, tissue damage, and the need for surgical intervention.
Zimmer, Inc. recalled the Affixus Antegrade Femoral Nail on December 2, 2025, due to a risk of fatigue fractures. The recall affects three units distributed nationwide across several states. Patients should stop using the device immediately and consult healthcare providers for further instructions.
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.
Zimmer Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, leading to potential health risks. Patients should stop using the devices immediately and contact their healthcare provider.
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.