China NMPA Product Recall - Genesis II Total Knee System

Smith & Nephew, Inc. initiated a voluntary Class II recall of its Genesis II Total Knee System, as announced by the National Medical Products Administration (NMPA) on September 7, 2022. The decision for the recall, reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., stemmed from a critical labeling error found in a specific model and batch of the product. The affected devices, registered under certificate number 20153463638, are subject to this recall to address the discrepancy and maintain product integrity. This action falls under the regulatory oversight of the NMPA, which hosts the public notification. Detailed information regarding the specific models, specifications, and batch numbers involved is available in the associated "Medical Device Notice" and "Medical Device Recall Event Report Form" attachments. The recall is a proactive measure to ensure the accuracy of product labeling and uphold patient safety standards.