Zimmer issued a recall for 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized diameter, risking fatigue fractures. This defect could lead to severe health complications for patients.
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 medical devices used for the stabilization of fractures in the femur. Surgeons typically use them in orthopedic procedures to ensure proper alignment and healing of bone fractures.
The defect in the distal diameter of the implants can lead to fatigue fractures, which may compromise the stability of the bone and lead to further complications.
This recall is not part of a broader industry pattern.
Patients using the affected implants face serious health risks, including the potential need for additional surgeries to address complications.
You can find the model number and lot codes on your surgical records or the device packaging if available.
Expect a timeline of 4-6 weeks for refund processing or further instructions from the manufacturer.
Keep all records related to your implant, including surgical notes, correspondence regarding the recall, and any symptoms experienced.
This recall affects the Affixus Antegrade Femoral Nails, model number 815509440. The product is 9 mm in diameter and 440 mm in length. The affected implants were distributed nationwide in various states.
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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.