China NMPA Product Recall - Hip joint surgical instrument kit

Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd. (also known as Shanghai Microport Orthopedic Medical Technology Co., Ltd.) initiated a voluntary Level II recall for its Hip Joint Surgical Instrument Kit, specifically involving the PPW38078 Quick-Release Handle. The company formally reported this recall to the National Medical Products Administration (NMPA) on February 1, 2017, with the information publicly released on April 6, 2017. The primary issue identified was a critical functional defect: the bone reamer component could not be properly locked onto the handle, and if forcibly locked, it could not be properly detached. This defect posed a significant safety and performance concern for the surgical instrument. Under the NMPA's regulatory framework for medical devices, the company took corrective action. All three units of the affected batch (US100122) that were previously imported into China had already been returned to the United States in September 2016. As a result, no products from this specific problematic batch are currently present in China, rendering further domestic action unnecessary. The recall also encompassed international markets, including Spain and Italy.