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 Affixus Antegrade Femoral Nail is a medical device used for stabilizing fractures in the femur. Surgeons typically use this device in orthopedic procedures to promote proper healing of bone fractures.
The defect in the device may lead to an undersized distal diameter, increasing the risk of implant fatigue fractures. This can result in serious health complications, including pain and the need for additional surgeries.
This recall is not part of a broader industry pattern.
Consumers affected by this recall may face significant health risks and potential surgical interventions, impacting recovery time and overall well-being.
The model and lot numbers are typically found on the packaging or the device label itself.
Expect a response from the manufacturer regarding the recall process within 4-6 weeks.
Keep all receipts, correspondence with the manufacturer, and any medical records related to your device.
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.
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