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 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.
The affected implants may have an undersized distal diameter along the shaft, increasing the risk of implant fatigue fracture. Such fractures can lead to adverse local tissue reactions, pain, non-union or malunion, and potential need for surgical intervention.
No specific incidents of injury or death have been reported at this time. The potential health risks associated with the device necessitate immediate action.
Patients and healthcare providers should cease use of the device immediately. Contact Zimmer, Inc. or your healthcare provider for further instructions on the recall process.
For more information, contact Zimmer, Inc. or visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0977-2026.
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