China NMPA Product Recall - Intramedullary nail system

The National Medical Products Administration (NMPA) published a recall notice on April 19, 2013, regarding specific intramedullary nail systems manufactured by Synthes GmbH. The voluntary recall was initiated due to a manufacturing error: an incorrect product number, 473.085, was laser-etched onto the product instead of the correct number, 473.080. Although the packaging correctly identified the product, this discrepancy led to the recall of affected batches, specifically batch number 5916720. The recall, reported to the State Food and Drug Administration (SFDA), a predecessor to the NMPA, was an overseas action and did not involve the Chinese market. Despite the product's registration in China, no units of the affected batch were imported or sold within the country. However, the NMPA mandated that provincial and municipal food and drug administration departments ensure diligent supervision and management of similar products. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., as the responsible unit in China, formally reported the overseas recall status to the regulatory authorities in March 2013.