China NMPA Product Recall - Anatomical bone plate (trade name: Synthes)

The National Medical Products Administration (NMPA) issued a notice regarding a voluntary product recall initiated by Synthes GmbH, Switzerland, for certain anatomical bone plates. This recall was reported on February 19, 2014, by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the product's distributor in China. The primary issue involved incorrect product labeling, where packaging for two distinct models, 221.334 and 221.333, was mixed, leading to 3-well plates being mislabeled as 4-well plates, and vice versa. While the manufacturer initiated the recall on February 10, 2014, in other countries, they confirmed that the affected batches were not imported or sold within China. Consequently, Johnson & Johnson Shanghai reported the situation to the State Food and Drug Administration (SFDA) but stated no further actions, investigations, or reports would be undertaken domestically due to the absence of affected products in the Chinese market. Regulatory bodies at the provincial, autonomous region, and municipal levels were advised to strengthen their management of similar medical devices.