China NMPA Product Recall - Power Tools

The National Medical Products Administration (NMPA) published details of a Class III voluntary recall initiated by The AnspachEffort, Inc. for its Power Systems, as reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. on August 7, 2017. The primary issue identified was the omission of a recommended maintenance period from the Instructions for Use (DFU) accompanying these power tools, which are intended for bone cutting and shaping, particularly in skull and spine procedures. No inspection dates were specified in the document, but the concern relates to products distributed after September 28, 2016. As a corrective measure, all Power Tools products received after this date will now be issued with an updated version of the DFU that includes the required maintenance schedule. Significantly, none of the affected products were sold in China, meaning the recall primarily addresses units in other international markets, such as the USA. This action ensures that users receive complete and crucial information for product upkeep, aligning with regulatory expectations for medical device documentation.