China NMPA Product Recall - Large Cannulated Screw System

Smith & Nephew, Inc., a medical device manufacturer, initiated a voluntary Class II recall of its Large Cannulated Screw System, as announced on October 15, 2021. This action was taken due to a significant labeling discrepancy where the product label incorrectly stated the screws were fully threaded, while the actual devices were only partially threaded. The recall affects specific models and batches of the Large Cannulated Screw System (Registration Certificate No.: 20153133639). Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. reported this issue, leading to the manufacturer's voluntary recall. This regulatory action falls under the oversight of the National Medical Products Administration (NMPA) in China. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company has voluntarily undertaken the necessary steps to address this issue. Further detailed information regarding the affected product models, specifications, and batches is available in the 'Medical Device Recall Event Report Form' provided by Smith & Nephew, Inc.