China NMPA Product Recall - Spinal internal fixation system

Medtronic Sofamor Danek Manufacturing, in collaboration with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class II recall of its spinal internal fixation system. This recall was reported by the National Medical Products Administration (NMPA) on July 4, 2023. The primary reason for this action is the use of incorrect materials in the manufacturing of the product's components. The NMPA's classification of this as a Class II recall signifies that the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company is undertaking necessary steps to remove the impacted devices from circulation. Comprehensive details, including specific affected product models, specifications, and batch numbers, are provided in the "Medical Device Recall Event Report Form" submitted by Medtronic (Shanghai) Management Co., Ltd. This voluntary recall highlights the critical need for strict material control and quality assurance throughout the medical device manufacturing process to safeguard patient well-being and product performance.