Zimmer recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025, due to a risk of implant fatigue fracture. Affected implants may cause serious health issues, including tissue damage and pain. Healthcare providers must stop using the device immediately and follow recall 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 Nail is a medical implant used in orthopedic surgeries to stabilize fractures in the femur. Surgeons choose this device for its design, which aids in proper healing of fractures through internal fixation.
The implant has an undersized distal diameter which can lead to fatigue fractures under stress. Such fractures pose serious health risks, including pain and the potential need for additional surgeries.
This recall is not part of a broader industry pattern.
Consumers with the affected implants may face significant health risks, including the need for corrective surgery and prolonged recovery times.
The model and lot numbers are typically found on the device packaging or in the surgical records provided by your healthcare provider.
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
Keep records of all communications regarding the recall, including dates, names of representatives, and any written correspondence.
The recalled product is the Affixus Antegrade Femoral Nail, model number 815609360, with a diameter of 9 mm and a length of 360 mm. It was distributed nationwide in the US, including states such as California and Texas. The device was available through multiple retailers.
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