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 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.
Affected implants may have an undersized distal diameter along the shaft, leading to fatigue fractures. This can result in local tissue reactions, pain, non-union or malunion, and tissue damage that requires surgical intervention.
No specific incident or injury counts are reported, but the potential health risks are significant. Patients may experience adverse reactions necessitating further medical procedures.
Stop using the device immediately. Follow the recall instructions provided by Zimmer, Inc. Contact your healthcare provider for further guidance.
For more information, visit the recall page at the FDA's website or contact Zimmer, Inc. directly for assistance.
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