China NMPA Product Recall - Orthopedic surgical navigation system

MAKO Surgical Corp., based in the USA, initiated a voluntary Class II recall of its orthopedic surgical navigation system due to a potential software error affecting specific product models and batches. The National Medical Products Administration (NMPA) published this recall information on November 23, 2020. The recall was reported by Stryker (Beijing) Medical Devices Co., Ltd., indicating an issue with the navigation system, which holds Registration Certificate No.: 20143015526. The NMPA oversees the regulatory framework for this action, emphasizing the manufacturer's proactive measure to address the identified software defect. Detailed information regarding the affected products is available in the associated "Medical Device Recall Event Report Form" provided by MAKO Surgical Corp. This voluntary recall aims to mitigate potential risks associated with the software malfunction, ensuring the safety and efficacy of the medical device in surgical applications.