China NMPA Product Recall - Trauma surgical instrument kit and orthopedic drill

The National Medical Products Administration (NMPA) published a recall notice on January 11, 2017, concerning trauma surgical instrument kits and orthopedic drills manufactured by Synthes GmbH and distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, initially reported by Johnson & Johnson on January 21, 2016, addresses a manufacturing defect in specific components. The flexible shaft (model 352.040) of the trauma surgical instrument kit and the movable extension rod (model 352.044) of the orthopedic drill were found to have asymmetrical hexagonal couplers. This defect results in uneven side lengths of the hexagon, which could prevent the flexible shaft from correctly matching with the head of its nested reamer, potentially affecting the functionality of these Class I medical devices.