China NMPA Product Recall - Dental thermocoagulation device

KaVo (Shanghai) Dental Medical Devices Co., Ltd., acting for manufacturer Ormco Corporation (USA), initiated a voluntary Level 3 recall for dental thermocoagulation devices, as reported on May 22, 2015. The affected products were shipped to China between January 28, 2015, and May 6, 2015. The main issue was an error on the Chinese labels, specifically incorrect medical device registration certificate numbers and after-sales service organization information. The company clarified that this labeling discrepancy did not affect the product's normal functionality or safety. Operating under the oversight of the National Medical Products Administration (NMPA), the company outlined specific corrective actions. For devices held in stock, KaVo (Shanghai) froze shipments and implemented a process to correct the labels. For products already shipped to customers, the company committed to sending recall letters through distributors, providing customers with the correct labels for self-application, thereby ensuring all devices bear accurate regulatory and service information.