China NMPA Product Recall - Dental implant accessories - standard abutment (including screws)

On September 10, 2021, the National Medical Products Administration (NMPA) published a recall notice regarding Dentsply Sirona Dental Products (Shanghai) Co., Ltd. The document detailed a voluntary recall initiated by Dentsply Implant Manufacturing Co., Ltd. for specific batches of its dental implant attachments. The main issue identified was the potential failure of these standard abutments, including their associated screws, to meet their intended functional specifications. The affected product, specifically batch number B210003056, is registered under 국械注进20163632336. This recall has been classified as Class III, indicating that the use of, or exposure to, the violative product is not likely to cause adverse health consequences. The regulatory oversight for this action is provided by the NMPA, operating under its medical device recall framework. As a required action, Dentsply Implant Manufacturing Co., Ltd. is undertaking the voluntary recall to ensure patient safety and product efficacy. Further comprehensive details regarding specific models, specifications, and the complete list of affected batches are available in the "Medical Device Recall Event Report Form," which stakeholders are directed to consult. This proactive measure by the manufacturer, overseen by the NMPA, aims to address the identified product deficiencies promptly.