Zimmer Inc. recalled 24 units of the Affixus Antegrade Femoral Nailing System on December 2, 2025. Affected implants may have an undersized distal diameter that could lead to implant fatigue fractures. Risks include pain, tissue damage, and potential 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 a medical device used in orthopedic surgeries for stabilizing femur fractures. Surgeons choose this device for its design and efficiency in implanting nails into the femur.
The recall is due to potential undersizing of the distal diameter of the implant, which may lead to fatigue fractures. Such fractures can compromise the integrity of the implant and harm surrounding tissues.
This recall is not part of a broader industry pattern.
Patients with the affected device may face significant health risks, including the possibility of needing additional surgery due to implant failure.
The model number and lot number can usually be found on the implant packaging or in the device records provided by your healthcare provider.
Expect processing for refunds or replacements to take around 4-8 weeks.
Keep all receipts, correspondence, and documentation related to the implant and recall for your records.
The recalled product is the Affixus Antegrade Femoral Nails, Model/Catalog Number 815609340. The affected size is 9 mm with a length of 340 mm. These products were distributed nationwide in several states including California, Texas, and Florida.
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