China NMPA Product Recall - Total knee system

Smith & Nephew Medical Ltd, a manufacturer of medical devices, initiated a voluntary Class III recall of its Total Knee Joint System (National Medical Device Registration Certificate 20153462894) due to a critical manufacturing error. The issue, officially reported on September 18, 2017, involved the incorrect installation of 5mm screws in certain products, where the correct specification required 10mm screws. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., the product's agent, reported this recall under the regulatory framework of the National Medical Products Administration (NMPA) of China. The affected product model is identified as 71421733, specifically