Zimmer recalled 22 Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, risking fatigue fractures. This can lead to serious health complications 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 Nailing System is used in orthopedic surgery to stabilize fractures in the femur. Surgeons and healthcare providers typically use these implants for patients recovering from femoral fractures.
The implants may have an undersized distal diameter, which can increase the risk of fatigue fractures. Such fractures can lead to severe complications including pain and the need for additional surgeries.
This recall is not part of a broader industry pattern.
Patients using the affected implants may face health risks that require surgical intervention and can suffer from pain or complications if not addressed promptly.
Model numbers and lot codes can typically be found on the packaging or directly on the implant itself, usually near the UDI label.
Expect a refund or replacement to take 4-8 weeks following the recall process.
Keep a record of all communications with the manufacturer, including letters, emails, and phone call notes.
The recall includes Affixus Antegrade Femoral Nails, model 815509360. The implants were distributed nationwide in states including California and Texas. The affected product has a 9 mm diameter and a length of 360 mm.
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