Affixus recalled 22 units of its antegrade femoral nailing system on December 2, 2025, due to a risk of implant fatigue fracture. The defect may lead to serious health complications including tissue damage and pain. Consumers and healthcare providers must stop using the affected implants immediately.
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 Nailing System is a medical device used to stabilize fractures of the femur. It is commonly used in orthopedic surgeries to provide structural support during healing.
The undersized distal diameter can lead to fatigue fractures, which compromise the implant's integrity and may require additional surgical interventions to correct.
This recall is not part of a broader industry pattern.
This recall poses significant risks to patients who may experience severe health complications, adding urgency for immediate action.
The model and lot numbers can typically be found on the packaging or documentation provided with the implant.
Expect a processing timeline of 4-6 weeks for refunds or replacements after contacting the manufacturer.
Keep all receipts, correspondence, and any medical records related to the implant for your records.
The recall involves the Affixus Antegrade Femoral Nails, model number 815509420. These implants were distributed nationwide in various states, including California and Texas. There is no price mentioned for the product.
Not sure what to do next? Our guide walks you through the process step by step.
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