China NMPA Product Recall - Total knee system

Smith & Nephew, Inc., a manufacturer of medical devices, initiated a voluntary Class III recall of its total knee joint system, as reported by its agent, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The recall was formally reported on December 19, 2018, and subsequently announced by the National Medical Products Administration (NMPA) on January 24, 2019. The central issue leading to this recall was an incorrect country of origin labeling; specific product batches, registered under National Medical Device Registration Certificate 20153463305, were manufactured in Malaysia but incorrectly labeled as originating from the United States. Affected products include specific Press-fit Type Extension Rods, identifiable by particular batch numbers. Although the recall scope includes regions such as Dubai, Mexico, and Puerto Rico, no sales of the implicated products were recorded in China. The NMPA oversees this regulatory action, requiring the voluntary recall to correct the labeling discrepancy, with detailed corrective actions and handling methods outlined in the submitted Medical Device Recall Event Report Form.