China NMPA Product Recall - Artificial bone substitutes

Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd., through its Taiwan entity, Taiwan Minimally Invasive Medical Devices Co., Ltd., has voluntarily initiated a Class III recall for its artificial bone substitutes (Registration Certificate No.: 20163460069). This recall was publicly announced on February 1, 2020, following an initial National Medical Products Administration (NMPA) publication on December 31, 2019. The primary reason for this action is a deviation from the company's internal labeling control procedures during the production of these medical devices. This procedural lapse required label adjustments that would be implemented through repackaging. To proactively mitigate any potential user confusion that could arise from varied information displayed before and after these label revisions, the company decided to recall the relevant products. Importantly, the recall document explicitly states that the affected artificial bone substitutes do not present any efficacy or safety risks to patients. The focus of this regulatory action, categorized as a Class III recall, is primarily on addressing administrative and informational discrepancies rather than immediate health hazards. The regulatory framework for this action is overseen by the National Medical Products Administration (NMPA), which published the notification. Specific details regarding the models, specifications, and batches subject to this recall are provided in an attached "Medical Device Recall Event Report Form." This voluntary recall demonstrates the company's commitment to maintaining precise product information and compliance with manufacturing quality systems, even when no direct patient harm is involved.