Zimmer Inc. recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have undersized distal diameters, leading to potential fractures. Users should stop using the product 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 Nailing System is used in orthopedic surgeries for stabilizing femoral fractures. Patients and healthcare providers choose this system for its reliability in promoting healing and stabilization during recovery.
The defect in the distal diameter of the implants may cause fatigue fractures which compromise the implant's integrity and function. This could lead to severe complications requiring further surgical intervention.
This recall is not part of a broader industry pattern.
Patients impacted by this recall may face significant health risks, necessitating medical evaluations and potential surgeries, which can lead to increased healthcare costs and prolonged recovery times.
You can find the model and lot numbers typically on the packaging or the implant itself, often etched or labeled on the side.
Expect a resolution process for refunds or replacements to take approximately 4-6 weeks.
Keep records of all communications with the manufacturer, healthcare providers, and any receipts or documentation related to the implant.
The recall involves Affixus Antegrade Femoral Nails, Model Number 815609380. The product was distributed nationwide across several states including California, Texas, and Florida. This model does not have a listed price.
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