China NMPA Product Recall - Craniofacial internal fixation system

The National Medical Products Administration (NMPA) issued an announcement on September 22, 2013, concerning a voluntary recall initiated by Synthes GmbH for its Craniofacial Surgery Internal Fixation System (Registration No.: CFDA (Imported) No. 3461735). This action was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The primary issue identified was a packaging error, specifically the discovery of an incorrect batch label (batch number 3373620) inside a product labeled as batch 3373621 (model 04.503.723S). This recall is an overseas action, impacting regions such as the United Kingdom and Japan, and does not directly involve products distributed within China. However, the product is registered for use in China. In response to this situation, the NMPA has instructed provincial, autonomous region, and municipal food and drug administrations to enhance their oversight and management of similar medical devices. The company's internal report to the State Food and Drug Administration regarding this issue was dated September 2008.