China NMPA Product Recall - Artificial Hip Modular System

On January 20, 2020, the National Medical Products Administration (NMPA) publicly reported a Class II voluntary recall initiated by Biomet Orthopedics for its Hip Modular System (Registration No. 20173461073). This recall was reported by Zimmer Medical (Shanghai) International Trading Co., Ltd. The primary reason for this action was a product label mismatch, indicating an error in the labeling information for the device. Operating under the regulatory framework of the NMPA, China's authority for medical product oversight, this Class II recall signifies a situation where the use of the affected product may lead to temporary or medically reversible adverse health consequences, or where serious health consequences are remote. The required actions involve the voluntary removal of the affected products from the market. Specific details regarding the models, specifications, and batch numbers of the impacted Hip Modular System units, along with the comprehensive recall process, are officially documented in the "Medical Device Recall Event Report Form." This measure is critical to ensure patient safety and to correct the identified labeling discrepancy in accordance with NMPA regulations.