China NMPA Product Recall - Joint surgery instrument pack

Shanghai Minimally Invasive Orthopedic Medical Technology Co., Ltd., under the regulatory oversight of the National Medical Products Administration (NMPA), initiated a voluntary Level II recall for a Hip Joint Surgical Instrument Kit. The recall, publicly reported on March 17, 2017, was prompted by a significant functional defect. It was discovered that the bone reamer, a component within the affected product (specifically, the PPW38078 Quick-Release Handle, batch US100122), could not be properly secured to its handle. Furthermore, if forcibly attached, the reamer could not be properly detached, posing a critical issue for surgical use. The manufacturer, Microport Orthopedics, Inc., identified three units of this problematic batch that had been imported into China. As a corrective action, all three affected units were returned to the United States in September 2016. Consequently, as no products from the identified batch remained in the Chinese market at the time of the recall report, no further actions were required within China. The recall also impacted regions including Spain and Italy.