China NMPA Product Recall - Anspach Micromax Pneumatic Drill

The AnspachEffort, Inc., a medical device manufacturer represented by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary Class III recall of its Anspach Micromax Pneumatic Drill. This recall was formally reported on August 7, 2017, and publicly noted by the National Medical Products Administration (NMPA) on September 18, 2017. The primary concern was the omission of a recommended maintenance period from the device's instructions for use (DFU), specifically for pneumatic bone surgery devices shipped after September 28, 2015. This constitutes a regulatory non-compliance in product documentation. Although a global recall was initiated by AnspachEffort, Inc., the