China NMPA Product Recall - Orthopedic surgical navigation system

The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by MAKO Surgical Corp. for its orthopedic surgical navigation system. Reported by Stryker (Beijing) Medical Devices Co., Ltd. on August 18, 2020, the recall addresses a critical program output error identified in specific models and batches of the device. This issue necessitates the system's removal from the market to prevent potential adverse health consequences, although the probability of serious harm is considered remote, typical for a Class II recall. The regulatory framework for this action falls under the NMPA's authority in China, which oversees medical device safety and compliance. The required actions involve the manufacturer, MAKO Surgical Corp., undertaking this voluntary recall to correct the identified deficiency. Further detailed information regarding the affected product models, specifications, and batches is available in the