China NMPA Product Recall - Power Tools

The National Medical Products Administration (NMPA) issued a notice on September 13, 2017, concerning a voluntary Class III recall initiated by medical device manufacturer The AnspachEffort, Inc., and reported by its agent, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall pertains to power systems designed for bone cutting and shaping, specifically for skull and spine applications. The primary issue identified was that the instructions for use (DFU) accompanying these products lacked a recommended maintenance period, which is crucial for product upkeep and user guidance. In response to this regulatory gap, The AnspachEffort, Inc. implemented a corrective action: all Power Tools products distributed after September 28, 2016, are now shipped with an updated DFU that includes the necessary maintenance schedule. The recall documentation clarifies that zero units of the affected products were sold or distributed in China, indicating the action primarily addresses global compliance standards and product information completeness rather than direct patient risk within the Chinese market.