China NMPA Product Recall - clamp

The National Medical Products Administration (NMPA) published a notice on January 27, 2016, concerning a voluntary recall initiated by Synthes GmbH, a manufacturer whose clamping devices are distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall pertains to orthopedic surgical clamps (Registration No.: 20150856) used for securing bone pins or screws. The core issue identified was that the adjusting caps of the affected products might be incompatible with the main device, potentially causing the two parts to separate and preventing the surgical tool from functioning as intended. Although this recall was reported by Johnson & Johnson on January 4, 2016, it was explicitly confirmed that no affected products were imported into or sold within China. Despite zero sales in China, the NMPA requested provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management of similar medical devices to uphold regulatory standards. Therefore, no direct corrective actions, such as product retrieval or repair, were required within the Chinese market.