China NMPA Product Recall - Intramedullary nail system for hip (trade name: Asian type)

The National Medical Products Administration (NMPA) announced on April 18, 2014, a voluntary recall initiated by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., for specific models of hip intramedullary nail systems. These medical devices are manufactured by Smith & Nephew Inc. and fall under the NMPA's Supervision and Management of Class A Products framework, with a CFDA Import Medical Device Registration Certificate. The recall, formally reported on March 27, 2014, and published on April 8, 2014, was necessitated by a production process error. This error resulted in an incomplete seal around the inner tray packaging of the product, although the outer packaging remained intact, maintaining sterility and indicating a low probability of infection. The affected products include models like 71660270 and 71660290, with 4 units sold in China from 11 imported. As required actions, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. is issuing recall notices to distributors and subsequently hospitals. The company is collecting returned products at its Shanghai warehouse before returning them to the U.S. manufacturing plant for processing, and will provide replacement products or refunds to distributors.