Zimmer recalled 11 Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may fracture, leading to serious health risks. Patients should stop using the device immediately and follow manufacturer 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 in orthopedic surgery to stabilize femur fractures. Surgeons choose this device for its ability to provide internal fixation to enhance healing.
The defect in the distal diameter of the nail can lead to fatigue fractures, causing serious complications that may require surgical intervention and can negatively affect recovery.
This recall is not part of a broader industry pattern.
Users of the affected devices may face significant health risks, necessitating additional surgeries and causing emotional distress.
You can find the model number and lot number on the packaging or directly on the device.
Expect a timeline of 4-6 weeks for processing refunds or replacements.
Keep a record of all communications, including emails and letters from the manufacturer, and photographs of the device if possible.
The recall involves Affixus Antegrade Femoral Nails, Model No 815609300. The product is 9 mm in diameter and 300 mm in length. The affected units were distributed in several states across the U.S.
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