China NMPA Product Recall - Locking plate

The National Medical Products Administration (NMPA) issued a notice on March 26, 2013, regarding a voluntary recall initiated by Synthes GmbH for certain batches of its locking bone plates (Registration No. CFDA 20113460280(Revised)). Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the responsible unit in China, reported the recall. The primary issue identified was incorrect labeling, where product model 241.267 was erroneously identified as 2276. This recall was an overseas action and did not involve any products sold or imported into the Chinese market. Therefore, the company did not implement further recall measures within China. However, in line with regulatory expectations, Johnson & Johnson (Shanghai) formally reported the incident to the State Food and Drug Administration (now NMPA). In response, provincial, autonomous region, and municipal food and drug administrations were instructed to strengthen their oversight and management of similar medical devices to maintain product safety standards, even though no affected units were present in China.