China NMPA Product Recall - Femoral stem system (trade name: SMF)

On March 1, 2019, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Femoral Stem System, marketed under the trade name SMF. This action was taken due to a critical labeling issue where the product's outer packaging displayed incorrect size information. The National Medical Products Administration (NMPA) serves as the overarching regulatory body overseeing this process. The affected medical device, holding registration certificates from the Shanghai Food and Drug Administration and CFDA (Imported), is being recalled to ensure patient safety and product integrity. As part of the required actions, Smith & Nephew has committed to providing detailed information regarding the specific models, specifications, and batch numbers of the impacted products in a comprehensive 'Medical Device Recall Event Report Form.' This measure is crucial for healthcare providers and facilities to identify and remove the recalled devices from circulation effectively. The voluntary nature of the recall underscores the company's responsibility in addressing product discrepancies and adhering to regulatory standards set forth by the NMPA.