China NMPA Product Recall - Trauma surgical instruments (trade name: SYNTHES); Orthopedic surgical instruments - reaming, perfusion, and suction systems (trade name: RIA)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting under the National Medical Products Administration (NMPA) framework, initiated a voluntary recall on July 16, 2015, for specific trauma surgical tools and orthopedic surgical instruments. The recall primarily targeted the Reaming, Perfusion, and Suction System (RIA), manufactured by Synthes GmbH. The main issue identified was the potential for the drive shaft, tubular assembly, and reamer head components to break during incorrect assembly or improper use. This could lead to instrument fragments remaining within the surgical site, causing potential surgical delays, adverse tissue reactions, or direct patient harm and pain. As a required action, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. destroyed all three affected product units imported into China, none of which had been sold. Additionally, the manufacturer issued an on-site safety notice and incorporated a precautionary statement into the RIA Surgical Technique Guidelines to inform users of these risks. Since the products did not reach the market, no further investigative or summary reports were deemed necessary beyond the initial notification to the Shanghai Food and Drug Administration.