China NMPA Product Recall - Hip joint assembly - bipolar head

The National Medical Products Administration (NMPA) has announced a voluntary Class III recall initiated by Biomet Orthopedics for certain hip joint components. Reported on June 14, 2024, by Zimmer Medical (Shanghai) International Trading Co., Ltd., the recall addresses a critical product integrity issue. The primary concern is the potential for incorrect assembly of the 41mm bipolar head with the 42mm locking ring, which could compromise the device's intended function and patient safety. The affected hip joint components are registered under National Medical Device Registration Certificate No. 20153133783. This action is a proactive measure by Biomet Orthopedics to withdraw all impacted batches from distribution. The recall is managed under the NMPA's regulatory framework, which classifies the seriousness of medical device issues. Comprehensive details regarding the specific models, specifications, and batch numbers of the recalled components are provided in the official "Medical Device Recall Event Report Form," ensuring full transparency and facilitating the necessary corrective actions to safeguard public health and maintain product quality standards.