China NMPA Product Recall - Spine Surgical Navigation and Positioning System

Mazor Robotics Ltd., in conjunction with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Level II recall of its Spine Surgical Navigation and Positioning System. This action, reported by Medtronic (Shanghai) on February 2, 2026, addresses critical software anomalies identified in version 5.1.1 of the device. The primary issues involve potential delays in the real-time screen display during surgical navigation and inconsistencies between the screw information presented on the screen and the actual screw data. These software malfunctions could compromise the precision and safety of spinal surgical procedures. Operating under the oversight of the National Medical Products Administration (NMPA) and in adherence to medical device regulations, including the National Medical Device Registration Certificate No. 20213010, Mazor Robotics Ltd. is taking proactive steps to mitigate risks to patient safety. The recall encompasses specific models, specifications, and batches of the affected product, with detailed information available in the "Medical Device Recall Event Report Form." This required action underscores the commitment to device integrity and patient well-being, necessitating the removal of affected systems from the market to prevent potential adverse events.