China NMPA Product Recall - Powered system mobile phone interface Powered system accessories

The AnspachEffort, Inc., facilitated by its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a Class III voluntary recall of its power system mobile phone interface. This action, reported to the National Medical Products Administration (NMPA) on August 7, 2017, and published on September 13, 2017, stemmed from an identified deficiency: the product's instructions for use lacked a recommended maintenance period. The affected devices, manufactured in the USA, are utilized in neurosurgical, ENT, spinal, and skull surgeries. Critically, no affected product models or batches were imported into or sold within China. Consequently, under the NMPA's regulatory oversight, no specific corrective actions were required from the agent in the Chinese market. The manufacturer's corrective measure involved updating the instructions for use to include the necessary maintenance period for all relevant units globally, particularly those received after September 28, 2016, ensuring compliance and user safety.