Zimmer Inc. recalled 24 units of Affixus Antegrade Femoral Nails on December 2, 2025. The recall follows reports of undersized distal diameters that could lead to implant fatigue fractures. This defect poses a high risk of adverse tissue reactions and requires immediate action.
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 bone fractures. Patients often receive these implants following severe fractures or surgical procedures to ensure proper healing.
The undersized distal diameter of the implants can lead to fatigue fractures, resulting in serious complications that may require additional surgery. This defect compromises the integrity of the implant, posing significant health risks.
This recall is not part of a broader industry pattern.
This recall may cause significant concern for patients who have undergone surgery with these implants. The potential for serious health complications necessitates immediate action.
Model numbers and lot codes are typically located on the packaging or documentation provided with the implant.
Expect a response regarding refunds or replacements within 4-6 weeks.
Keep all correspondence with Zimmer Inc. and records of your implant details for future reference.
The recalled product is the Affixus Antegrade Femoral Nail, model number 815609400. It consists of a 9 mm diameter and 400 mm length nail. Sold nationwide in various states, it is part of Zimmer's medical device lineup.
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