Zimmer recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, leading to potential fatigue fractures. Health risks include pain, tissue damage, and the need for 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 involves Affixus Antegrade Femoral Nails, model number 815609420, with a diameter of 9 mm and a length of 420 mm. The affected products were distributed nationwide across multiple states.
Affected implants may have an undersized distal diameter along the shaft. This defect could lead to implant fatigue fractures, resulting in adverse reactions, pain, or the need for further surgery.
As of the recall date, no specific incidents or injuries have been reported. However, potential risks include pain, non-union, malunion, and tissue damage.
Patients and healthcare providers must stop using the affected device immediately. Contact Zimmer, Inc. or your healthcare provider for further instructions regarding the recall.
For questions, call Zimmer at 1-800-123-4567 or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0980-2026.
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