China NMPA Product Recall - Knee Instrument (Knee Joint Surgical Tools)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of DePuy Orthopaedics, Inc., initiated a voluntary Level II recall of specific knee surgical instruments, as reported on September 29, 2020. This action was taken under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The primary issue identified was a manufacturing defect where the drilled hole in the joint portion of certain instruments did not fully penetrate the cutter, thus obstructing the passage of a positioning rod. This critical flaw could impair the proper function of the surgical instrument during medical procedures. The initial recall, referenced as "Shanghai Food and Drug Administration Medical Device Recall 2020-016," was subsequently expanded to include additional products. Specifically, the expanded scope now covers instruments with model number 96-6115 and batch numbers SO2040602 and SO2037408. This voluntary recall aims to mitigate potential risks to patient safety by removing affected devices from circulation and ensuring compliance with medical device quality standards.