Zimmer recalled 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, risking fatigue fractures. This can lead to serious health complications requiring surgical intervention.
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 recall includes Affixus Antegrade Femoral Nails, model 815509360. The implants were distributed nationwide in states including California and Texas. The affected product has a 9 mm diameter and a length of 360 mm.
Affected implants may have an undersized distal diameter along the shaft. This defect could lead to implant fatigue fracture, resulting in adverse local tissue reactions, pain, non-union or malunion, and potential tissue damage.
There are no reported incidents of injuries or deaths associated with this recall. However, the potential health risks are significant if fatigue fractures occur.
Patients and healthcare providers must stop using the device immediately. Contact Zimmer, Inc. or your healthcare provider for further instructions and follow the recall instructions provided.
For more information, call Zimmer, Inc. at (877) 946-2761 or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0969-2026.
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