China NMPA Product Recall - Screwdriver

KaVo (Shanghai) Dental Medical Devices Co., Ltd. initiated a voluntary Class III recall of screwdrivers (Registration Certificate No.: 国械备20151817号). The recall, publicly reported on June 10, 2020, by the National Medical Products Administration (NMPA) via the Shanghai Municipal Drug Administration, was prompted by a critical discrepancy. Specifically, the material number 601-0012, associated with batch number 05196368, was found to be incorrectly labeled on the outer packaging compared to the actual product contained within. This issue, while not detailed further in its potential impact, warranted the company's proactive measure to retrieve the affected dental medical devices from the market. The regulatory framework overseeing this action includes the NMPA, which hosts the official recall information, and the Shanghai Municipal Drug Administration, which served as the source for the initial recall notification. KaVo's required action was to execute this voluntary recall, addressing the packaging error to ensure product integrity and accurate identification for users.