China NMPA Product Recall - Cervical artificial intervertebral disc (trade name: Prodisc-C Vivo)

Synthes GmbH initiated a voluntary recall of its cervical artificial intervertebral disc, Prodisc-C Vivo (Registration Certificate No.: CFDA (Imported) 2013 No. 3465064). This recall was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the product's distributor in China, on July 28, 2016, and subsequently published by the National Medical Products Administration (NMPA) on August 10, 2016. The central issue identified was a missing high-density polyethylene (HDPE) synthetic paper cap in the inner blister packaging of the medical device. While the double-barrier packaging ensured the implant's sterility remained intact, this packaging anomaly was deemed capable of causing delays in surgical procedures. Operating under the regulatory framework of the NMPA, the manufacturer decided to recall the product. Crucially, the affected product batches were not imported into or sold within China. Therefore, no specific corrective actions were mandated for the Chinese market from Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. Nevertheless, the food and drug administrations across China's autonomous regions and municipalities were directed to enhance their supervision and management of similar medical devices.