Zimmer, Inc. recalled the Affixus Antegrade Femoral Nail on December 2, 2025, due to a risk of fatigue fractures. The recall affects three units distributed nationwide across several states. Patients should stop using the device immediately and consult healthcare providers for further 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 815809280, measuring 9 mm by 280 mm. This product was distributed nationwide in states including Florida, Texas, and California. Specific lot number is 67066287.
The implants may have an undersized distal diameter along the length of the shaft. This defect can lead to implant fatigue fracture, resulting in adverse local tissue reactions, pain, or additional surgical interventions.
No specific incidents have been reported to date, but the potential risks include non-union or malunion of the bone, which may necessitate further surgical intervention.
Patients and healthcare providers must stop using the affected device immediately. Follow the recall instructions from the manufacturer and contact Zimmer, Inc. for further guidance.
For more information, contact Zimmer, Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0982-2026.
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