China NMPA Product Recall - Biological acetabular cup system

DePuy Orthopaedics, Inc., supported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall concerning its biological acetabular cup system. The recall report was submitted on January 4, 2017, with public notification by the National Medical Products Administration (NMPA) on January 13, 2017, identified under NMPA Index No. JGXX-2017-10056. The central issue involved the distribution of 10 units of the product in Japan, which were manufactured by a company not formally registered. These specific units, falling under Registration Certificate No. 20153460710, were distributed to hospitals in Japan. Importantly, DePuy Orthopaedics confirmed that no affected products were imported into or sold within China. Consequently, no direct corrective actions were necessitated for the Chinese market. However, the NMPA instructed all provincial Food and Drug Administrations to reinforce their oversight and management of similar medical devices to proactively address potential compliance issues related to unregistered manufacturers.