China NMPA Product Recall - Total Knee Joint System - Zirconium-Niobium Alloy Femoral Condyle

Smith & Nephew, Inc., through its local entity Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for specific batches of its Total Knee Joint System - Zirconium-Niobium Alloy Femoral Condyle. This recall, formally reported on September 15, 2023, was prompted by identified packaging errors affecting some of these medical devices. The primary concern is the potential for incorrect product information or integrity due to these packaging issues, although the specific risks are considered less severe than those warranting a Class I recall.

The regulatory oversight for this action is provided by the National Medical Products Administration (NMPA) in China. A Class II recall signifies that the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. As a required action, Smith & Nephew is actively removing the impacted products from the market. The specific models, specifications, and batch numbers subject to this recall are detailed in the accompanying Medical Device Recall Event Report Form, ensuring comprehensive identification and retrieval of the affected devices to safeguard patient safety and maintain product quality standards.