China NMPA Product Recall - Anatomical bone plate

The National Medical Products Administration (NMPA) issued a notice on July 29, 2016, regarding a voluntary recall of anatomical bone plates manufactured by Synthes GmbH and distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, formally reported on July 1, 2016, was initiated because the instruction manuals accompanying the product contained MRI safety information that did not conform to current American Society for Testing and Materials (ASTM) standards. The recall primarily impacted regions such as the USA and Canada. Importantly, no units of the affected anatomical bone plates were imported or sold within the Chinese market, negating the need for direct product-related corrective actions in China. However, the NMPA mandated that provincial and municipal food and drug administrations enhance their supervision and management of similar medical devices to ensure future compliance with safety and documentation standards.