China NMPA Product Recall - Manual tools for total hip replacement surgery

Smith & Nephew, Inc., a medical device manufacturer, initiated a voluntary Class III recall of its manual tools for total hip replacement surgery. The recall was reported to the National Medical Products Administration (NMPA) and related provincial authorities in China on October 30, 2017, by its agent, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.The primary issue prompting this action was the discovery of incorrect expiration dates printed on the labels of the affected manual surgical tools. These tools are registered under National Medical Device Registration Certificate 20140087 and are specifically designed for the assembly of orthopedic hip joint implants and bone fusion products during hip replacement procedures.While the document indicates that products were distributed in countries like the USA and Australia, the recall report specifically addresses actions within China. The company's voluntary recall demonstrates adherence to regulatory responsibilities under the NMPA framework. Smith & Nephew took the required action to recall the affected batches, ensuring patient safety by rectifying the labeling error on critical surgical instruments.