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

Smith & Nephew, Inc., in collaboration with its subsidiary Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall concerning its manual tools designed for total hip replacement surgery. This regulatory action was announced by the National Medical Products Administration (NMPA) on November 27, 2017. The primary issue prompting the recall was the discovery of incorrect expiration dates printed on the labels of these surgical instruments. This labeling inaccuracy presented a potential risk related to the proper management of product shelf-life. Operating under the regulatory framework of the NMPA, which ensures medical product safety and quality, Smith & Nephew took the required action of voluntarily removing the affected products, identified by Registration Certificate Code: "国械备20140087," from the market. This measure aimed to proactively mitigate any potential risks stemming from the mislabeled expiration information, highlighting the critical importance of precise labeling in maintaining medical device integrity and patient safety.