Mazor Robotics recalled 549 Mazor X robotic guidance systems on December 10, 2025, due to software errors. These errors may cause incorrect surgical instrument positioning during spinal surgeries. Patients and healthcare providers must stop using the device immediately.
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Mazor Robotics Ltd or your healthcare provider for instructions. Notification method: Letter
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The recall affects Mazor X robotic guidance systems with software versions 5.0.1, 5.1.2, and 5.1.3. These systems were distributed worldwide, including in the United States, Canada, and several European countries. The systems are classified as Class II medical devices.
Software errors can lead to incorrect positioning of surgical instruments, posing a high risk during spinal surgery. Improper positioning may result in severe consequences for patients, including increased risk of complications.
There are no specific injury counts reported at this time. However, the potential for significant harm exists due to the nature of the software errors.
Stop using the Mazor X robotic guidance system immediately. Contact Mazor Robotics Ltd or your healthcare provider for further instructions on the recall process.
For more information, call Mazor Robotics Ltd or visit their website. Details are available at the FDA's recall report page.
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