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 Affixus Antegrade Femoral Nails are used in surgical procedures for stabilizing femoral fractures. These medical devices are critical for patients recovering from bone injuries and surgeries.
The undersized distal diameter along the length of the shaft can compromise the structural integrity of the implant, leading to fractures that pose significant health risks.
This recall is not part of a broader industry pattern.
Consumers affected by this recall face immediate health risks that may require surgical intervention, leading to potential delays in recovery and increased medical costs.
Model numbers and lot numbers can typically be found on the packaging or the device itself.
Expect a realistic timeline of about 4-6 weeks for processing any refund or replacement requests.
Keep all correspondence related to the recall, including emails, letters, and notes from phone calls.
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.
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