Zimmer, Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, risking implant fatigue fracture. This defect can cause severe health issues, including pain and tissue damage requiring surgery.
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 Nails, Model/Catalog Number 815609320. The implants were distributed nationwide across several states including California and Texas. They are not priced in the recall data.
The implants may have an undersized distal diameter along the shaft. This defect can lead to implant fatigue fractures, resulting in adverse local tissue reactions, pain, and potential surgical intervention.
There are no specific reported incidents of injury or death associated with this recall. However, the risk of serious complications has been emphasized due to the potential for implant fatigue fractures.
Patients and healthcare providers must stop using the affected implants immediately. Follow the recall instructions from Zimmer, Inc. and consult with your healthcare provider for next steps.
For more information, contact Zimmer, Inc. directly or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0975-2026.
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