China NMPA Product Recall - Power tools (Product name: EMax 2 Plus System)

The National Medical Products Administration (NMPA) published details on September 13, 2017, concerning a Class III voluntary recall initiated by The AnspachEffort, Inc., a medical device manufacturer. This recall was reported by their agent, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on August 7, 2017. The core issue prompting the recall of various Power Systems, including models like EMax 2 Plus and EPLUS-FP, was the omission of a recommended maintenance period within the products' instructions for use. These power systems are specifically designed for critical procedures such as bone cutting and shaping, particularly involving the skull and spine. The regulatory framework governing this recall in China falls under Certificate No. CFDA (Imported) 2013 No. 2102973. As a required action, The AnspachEffort, Inc. is voluntarily recalling the affected power systems and has committed to updating future product documentation, specifically for EM6x6 Power systems, to include the necessary maintenance period information. While the recall documentation notes global involvement, it explicitly states that the directly affected model (EPLUS-FP) was not sold in China, indicating the NMPA's publication serves as an official notification within their jurisdiction regarding a manufacturer's broader corrective action.