China NMPA Product Recall - Vanguard 360 Revision Knee System - A modular total knee system

On December 21, 2020, Zimmer Medical (Shanghai) International Trading Co., Ltd. announced a voluntary Class II recall initiated by its manufacturer, Biomet Orthopedics. The affected product is the Vanguard 360 Revision Knee System, registered with NMPA Certificate No.: 20153462419. The reason for the recall stems from an incorrect component configuration found within the packaging of specific models and batches of the device. This issue led Biomet Orthopedics to proactively remove these products from the market. The recall operates under the regulatory framework of China's National Medical Products Administration (NMPA). While the document does not specify inspection dates, the company's action demonstrates compliance with regulatory expectations for product safety and quality. The Class II classification indicates that the issue could potentially cause temporary or reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. As part of the required actions, detailed information regarding the specific product models, specifications, and affected batches is documented in a separate "Medical Device Recall Event Report Form," enabling proper identification and management of the recalled devices.