Zimmer, Inc. recalled 11 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, posing a risk of fatigue fracture. This defect could cause adverse reactions requiring 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 Affixus Antegrade Femoral Nails are used in orthopedic surgeries to stabilize fractures in the femur. Surgeons choose this product for its design that facilitates easier implantation and durability under stress.
The undersized distal diameter along the length of the nail increases the risk of fatigue fractures. These fractures can lead to serious complications, including pain and the need for additional surgeries.
This recall is not part of a broader industry pattern.
Consumers may face significant health risks if they have undergone surgery with an affected implant, necessitating monitoring and possible surgical intervention.
The model and lot numbers are usually found on the packaging and patient information leaflets provided with the device.
Expect refund processes to take approximately 4-6 weeks after submitting your information.
Keep all receipts, recall notifications, and any correspondence with the manufacturer as records.
The recalled product is the Affixus Antegrade Femoral Nails, Model 815509300. It consists of a 9 mm diameter nail, 300 mm in length, designed for surgical applications. The affected units were distributed nationwide in several states including California and Florida.
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