China NMPA Product Recall - Total Knee System - Oxinium femoral implant, Journey II knee system

Smith & Nephew, Inc., a medical technology company based in the USA, has proactively initiated a voluntary Class II recall concerning specific models and batches of its Total Knee System - Oxinium femoral implant and Journey II knee system. This action, facilitated by its Chinese affiliate, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., was officially reported to the National Medical Products Administration (NMPA) of China on May 6, 2022. The core issue prompting this recall stems from critical errors identified within the product labeling information. Such discrepancies can potentially lead to misidentification of devices, incorrect usage, or inadequate information for healthcare professionals, thereby posing a risk to patient safety. The document does not refer to specific inspection dates but rather details a company-initiated recall. Operating under the regulatory framework of the NMPA, the required action involves the comprehensive retrieval of all affected units of the Total Knee System - Oxinium femoral implant and Journey II knee system from the market. The Class II recall classification indicates that while the possibility of serious adverse health consequences is considered remote, the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. This diligent measure underscores the company's commitment to product integrity and adherence to stringent medical device regulatory standards, aiming to mitigate any potential risks associated with the mislabeled products.