China NMPA Product Recall - Metal-surfaced replacement of femoral components of hip joint, hip replacement system

Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on behalf of its manufacturer Smith & Nephew Orthopaedics Ltd., initiated a voluntary recall of specific Metal-Surface Hip Replacement Femoral Components and Hip Replacement Systems. This action, reported on January 28, 2015, and published by the National Medical Products Administration (NMPA) on February 15, 2015, was prompted by company research and market monitoring. The findings indicated that certain patient demographics—women, men aged 65 or older, and individuals with implanted head sizes smaller than 48mm—might face elevated risks of premature revision surgery for these devices. The recall primarily involves updating the product's instructions for use to include these newly identified warning details. It is crucial to note that this measure is not a result of any product design flaw or quality defect but rather an enhancement to user information based on post-market surveillance. The affected products, registered under CFDA (Imported) Certificates No. 20133462179 and 20143463231, are used in hip replacement surgeries. Required actions involve the company's Quality Department drafting recall notices, the Sales Department informing distributors, and distributors relaying information to hospitals. All relevant documentation, including recall notice receipts, are to be collected and filed by the Quality Department, adhering to NMPA oversight.