China NMPA Product Recall - Steel plate screw tool system

The National Medical Products Administration (NMPA) published a notice on September 13, 2017, concerning a voluntary Class III recall initiated by Smith & Nephew, Inc., for its Plate Screw Tool System. The recall stemmed from a manufacturing defect where the screw removal device lacked a crucial mounting slot, preventing the tool from connecting properly with screws for implantation or removal. This issue affected products with Registration No. 20161364 and model/specification 71177169 16FTMH054. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., the agent in China, submitted the Medical Device Recall Event Report Form on August 7, 2017.

Under the NMPA's regulatory framework for medical device oversight, Smith & Nephew, Inc. voluntarily initiated this recall. While the Plate Screw Tool System is used in orthopedic surgery for bone plate and screw implantation, the report explicitly confirmed that this specific recall "does not affect China." No affected products were sold or distributed within the Chinese market. Therefore, although the company took corrective action by recalling the defective tools in other regions (e.g., Australia, Switzerland, Norway, Russia, Sweden), no specific actions were required for Chinese distributors or consumers.