China NMPA Product Recall - Synthetic resin teeth

Gusha Dental Co., Ltd. issued a voluntary Class III recall for its synthetic resin teeth, as announced on October 29, 2021, by the National Medical Products Administration (NMPA). This recall was initiated following findings from routine random inspections, which revealed quality deficiencies, specifically the presence of porosity on the surface of the crowns of the affected dental products. The issues identified posed a potential concern regarding the product's quality and performance. The recall encompasses synthetic resin teeth registered under Certificate No. "国械注准20173630704". Comprehensive details regarding the specific models, specifications, and batch numbers of the impacted devices are provided in the "Medical Device Recall Event Report Form" available for download. This action highlights the regulatory framework governed by both the NMPA and the Shanghai Municipal Drug Administration, which oversee medical device safety and compliance. Gusha Dental Co., Ltd. is undertaking this recall to address the identified manufacturing defects and ensure patient safety. Customers and distributors of the affected synthetic resin teeth are advised to refer to the official recall documentation for necessary actions and further guidance on handling the recalled products.