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.
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 in surgeries for bone fixation, particularly in femoral fractures. These implants help stabilize bones during the healing process.
The undersized distal diameter along the length of the shaft may lead to fatigue fractures, which can compromise the integrity of the implant and cause significant health issues.
This recall is not part of a broader industry pattern.
Consumers may experience delays in recovery and potential complications requiring further medical intervention, impacting their overall health and mobility.
Model numbers and lot codes can typically be found on the packaging or documentation provided with the device.
Expect a refund or replacement timeline of 4-6 weeks after processing your return.
Keep copies of all correspondence with the manufacturer and any medical documentation related to the implant.
The recall affects Affixus Antegrade Femoral Nails, Model No 815509380. The product was distributed nationwide in the United States, including states such as California and Texas.
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