China NMPA Product Recall - Dental implant machine

Foshan Dengtuo Medical Device Co., Ltd. initiated a voluntary Class III recall of its dental implant machine, specifically affecting products from production batch number SN21J16. This action, published on August 15, 2022, by the National Medical Products Administration (NMPA) through the Guangdong Provincial Drug Administration, was prompted by a critical quality control failure. During routine product sampling, the affected dental implant machines failed the no-load speed test, indicating a deviation from established performance specifications. The recall underscores the company's adherence to national requirements for medical device safety and quality. The dental implant machine, registered under certificate number 粤械注准20202171280, is subject to this recall due to the identified performance deficiency. A Class III recall typically signifies that the use of or exposure to a violative product is not likely to cause adverse health consequences. As part of its responsibility, Foshan Dengtuo Medical Device Co., Ltd. is required to manage the retrieval and proper handling of all affected units, ensuring they are removed from the market. The recall process involves detailed reporting, as outlined in the "Medical Device Recall Event Report Form," which specifies the types and batch numbers of all impacted products. This proactive measure aims to safeguard patient safety and maintain product integrity in the medical device sector.