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

Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. voluntarily reported a Class III recall for manual tools used in total hip replacement surgery, manufactured by Smith & Nephew, Inc. This report was published by the National Medical Products Administration (NMPA) on November 23, 2017, based on a submission dated October 30, 2017. The critical issue identified was incorrect expiration dates printed on the labels of these surgical tools. Although the recall was formally reported by the Chinese agent to the Provincial Food and Drug Administration, the affected product batches were primarily distributed and sold in the USA and Australia. The report explicitly states that there were no sales of the specific affected products within the Chinese market. This voluntary action ensures regulatory transparency regarding the product safety issue, even if the immediate impact of the recalled batches is outside of China. The company provided detailed information in a "Medical Device Recall Event Report Form" to outline the scope and corrective measures.