China NMPA Product Recall - TWINFIX Dual Fixed Anchor System

Smith & Nephew, Inc. Endoscopy Division, through its Chinese affiliate Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., initiated a voluntary recall for its TWINFIX Dual Fixation Anchor System. This action was reported on February 28, 2011, and subsequently publicized by the National Medical Products Administration (NMPA) on April 1, 2011. The core issue necessitating the recall was the presence of incorrect specifications on the product's English label, affecting the accuracy of product information for a device used in surgical soft tissue repair. The recall involved 11 imported units of product model 7210302, batch number 50327209. Crucially, none of these affected products had been sold or utilized; they were promptly isolated in a Shanghai warehouse. Smith & Nephew's immediate and required action involved returning these products to the overseas production department for handling by their US Endoscopy Division. The company committed to completing the recall process within one week, demonstrating compliance with the NMPA's regulatory expectations for medical device recalls.