China NMPA Product Recall - Computer-assisted surgical device for neurosurgery and spinal surgery

On September 24, 2021, Zimmer Medical (Shanghai) International Trading Co., Ltd. announced a voluntary Class II recall concerning a Computer-Assisted Surgical Device for Neurosurgery and Spinal Surgery. This action was initiated by MEDTECH S.A., the manufacturer, after a software malfunction was identified in specific serial numbers of the product. This critical issue carries the risk of inaccurate electrode placement during neurosurgical procedures, potentially compromising patient safety and surgical outcomes. The National Medical Products Administration (NMPA) supervised this regulatory action, classifying it as a Class II recall, which indicates a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Zimmer Medical (Shanghai) International Trading Co., Ltd. is undertaking the necessary actions to remove the affected devices from circulation, ensuring compliance with the regulatory standards set by the NMPA and mitigating potential risks to patients. Further details on specific models and batches are provided in the accompanying Medical Device Recall Event Report Form.