China NMPA Product Recall - Biological acetabular cup system

The National Medical Products Administration (NMPA) issued a recall notice concerning DePuy Orthopaedics, Inc.'s Biological Acetabular Cup System. This recall, initiated by DePuy Orthopaedics, Inc., primarily affected products distributed in Japan. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported this incident to the NMPA on January 4, 2017, with the official notice published on January 24, 2017.

The core issue stemmed from ten units of the biological acetabular cup system, identified by Registration Certificate No.: 20153460710. These units were manufactured by a specific company but lacked proper registration in Japan before being imported and distributed to hospitals in that country. This highlights a critical oversight regarding product registration status for distributed medical devices.

Under the NMPA's regulatory framework, while the recall was implemented in Japan, DePuy Orthopaedics, Inc. confirmed that no affected products were imported into China. Therefore, no direct corrective actions were mandated for the product within China. However, the NMPA instructed provincial, autonomous region, and municipal food and drug administrations to strengthen their supervision and management of similar medical devices to mitigate the risk of unregistered products entering the market in the future.