China NMPA Product Recall - Anspach Micromax Pneumatic Drill, a pneumatic bone tissue surgical device

The National Medical Products Administration (NMPA) published a notice regarding a voluntary Class III recall initiated by The AnspachEffort, Inc., through its agent Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, officially published on September 13, 2017, concerned the Anspach Micromax Pneumatic Drill, a device used for bone tissue surgery. The core issue identified was that the device's instructions for use (DFU) did not include a recommended maintenance period.

In response, the manufacturer stated that an updated version of the instructions, incorporating the necessary warranty period information, would accompany all pneumatic bone tissue surgical devices shipped after September 28, 2016. Crucially, the detailed recall report, dated August 7, 2017, confirmed that no units of the specific affected product models were imported or sold within China. Therefore, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. concluded that no direct corrective actions were necessary for the Chinese market, as the identified documentation deficiency did not affect products distributed in their region. This action reflects the company's adherence to regulatory standards.