China NMPA Product Recall - A2 color, B468 type, full denture multi-layered synthetic resin teeth

On September 26, 2021, Shanghai Medical Instruments Co., Ltd. Dental Materials Factory initiated a voluntary Level II recall for specific batches of its multi-color synthetic resin teeth. This critical action was prompted by the identification of significant quality issues, specifically 'porosity and other defects,' within batch number 201506 of the A2 color B468 type full-mouth synthetic resin teeth. These defects were discovered during a routine national sampling inspection, highlighting a deviation from established product quality standards. The recall was initiated and reported by Shanghai Medical Instruments Co., Ltd. Dental Materials Factory to the Shanghai Municipal Drug Administration, operating within the comprehensive regulatory framework of China's National Medical Products Administration (NMPA). A Level II recall signifies that the product might cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company is taking this proactive measure to mitigate potential risks associated with the defective dental materials and to ensure public health and safety. Required actions involve the retrieval of all affected products from the market. Further detailed information regarding the affected product models, specifications, and specific batch numbers is accessible through the 'Medical Device Recall Event Report Form' provided by the NMPA.