China NMPA Product Recall - Spinal Surgical Implants - Screws for Anterior Cervical Locking Plate

Synthes GmbH, a subsidiary of Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall for its spinal surgery implants—screws for anterior cervical locking plates (Model 450.016, NMPA Registration No. 20153462717). The recall was reported on January 19, 2016, and published by the National Medical Products Administration (NMPA) on February 25, 2016. The core issue was a labeling and packaging error where a specific batch of screws was incorrectly packaged with labels intended for other screw types. Critically, the company confirmed that the affected products were not distributed or sold within China, and no related complaints were reported in the country. Under the regulatory oversight of the NMPA, since the products were not in the Chinese market, no direct corrective actions were mandated for the company in China. However, the NMPA requested provincial food and drug administrations to enhance their management and oversight of similar medical devices.