China NMPA Product Recall - Bone screws

On February 26, 2014, the National Medical Products Administration (NMPA) publicized a voluntary recall initiated by the manufacturer, Synthes GmbH, concerning specific batches of bone screws. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the product's distributor in China, formally reported this global recall on February 19, 2014. The critical issue identified was that screws from affected batches, specifically model 404.012 with batch number 3008521, possessed unthreaded tips and measured 2mm longer than their expected 12mm length, representing a deviation from product specifications.

Operating within China's regulatory framework under the NMPA, it was confirmed that the affected bone screw batches had not been imported into or distributed within China. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. declared that, beyond the initial recall report submitted to the State Food and Drug Administration (SFDA), no additional actions, such as further investigations, assessment reports, or recall plans, would be implemented by the company in China. Nonetheless, the NMPA directed provincial food and drug administration departments across China to supervise and manage similar medical devices, ensuring continued oversight of product quality and safety, even for globally recalled items not directly affecting the domestic market.