China NMPA Product Recall - Spinal surgery navigation and positioning system

The National Medical Products Administration (NMPA) issued notice JGXX-2023-10206 on November 1, 2023, announcing a voluntary Class II recall of the Spinal Surgery Navigation and Positioning System manufactured by Mazor Robotics Ltd. This action was reported by Medtronic (Shanghai) Management Co., Ltd. The primary reason for the recall, which pertains to products registered under certificate No. 20213010107, is the discovery of incorrect packaging of screws in certain units of the device. A Class II recall indicates that exposure to the affected product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote. Mazor Robotics Ltd. is undertaking this recall to address the packaging discrepancy and ensure product safety. Detailed information concerning the specific affected product models, specifications, and batch numbers, along with required actions for stakeholders, is contained within the accompanying "Medical Device Recall Event Report Form." Parties in possession of these systems should consult the attachment for precise guidance on identifying and handling the recalled devices.