China NMPA Product Recall - Dental Ingots (IPS e.max)

Ivoclar Vivadent (Shanghai) Trading Co., Ltd. reported a voluntary Class III recall initiated by its manufacturer, Ivoclar Vivadent AG, concerning specific batches of dental all-ceramic blocks, marketed as IPS e.max Dental Ingots (Registration Certificate No.: 20142176059). The National Medical Products Administration (NMPA) published this information on April 22, 2020, following the report from the Shanghai Municipal Drug Administration. The primary issue prompting this recall is the potential for cracking in restorative materials fabricated from these dental blocks post-sintering. This defect could compromise the integrity and performance of dental restorations, posing a risk to patient safety and product efficacy. Under the oversight of the NMPA, Ivoclar Vivadent AG has taken the required action of a voluntary recall to address this product defect. A Class III recall typically signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Specific details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential risks associated with the faulty dental materials and ensure compliance with medical device quality standards.