Zimmer recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025, due to potential implant fatigue fractures. The defective implants could cause severe health risks, including pain, tissue damage, and the need for additional surgery. Healthcare providers and patients must cease use immediately and follow recall protocols.
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 recall involves the Affixus Antegrade Femoral Nails, model number 815609440. The affected product includes 9 mm nails with a length of 440 mm. These products were distributed nationwide across multiple states in the U.S.
Affected implants may have an undersized distal diameter along the shaft. This defect increases the risk of implant fatigue fractures, which can lead to adverse tissue reactions and severe pain.
There are no reported injuries or deaths linked to this recall. However, potential risks include non-union or malunion of bone and tissue damage requiring surgical intervention.
Patients and healthcare providers should stop using the affected implants immediately. Contact Zimmer, Inc. or your healthcare provider for further instructions. Follow the recall instructions provided.
For more details, patients can contact Zimmer, Inc. at their official website or via the recall notification letter.
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