China NMPA Product Recall - Hip replacement system

Smith & Nephew Orthopaedics Ltd. initiated a voluntary Class III recall of its hip replacement system, as reported by the National Medical Products Administration (NMPA) on July 4, 2017. The recall was prompted by a manufacturing process error, specifically an incorrect assembly of the steel cable within the hip replacement system. This defect could prevent the cable from being properly attached to the implant, particularly with curved or eccentric acetabular cup components. The recall event form, submitted by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on May 8, 2017, detailed the affected product models and batch numbers (e.g., 74120156, 16FW05491). Under the NMPA framework, a Class III recall indicates a situation where there is a low probability that use of, or exposure to, a violative product will cause adverse health consequences. Crucially, the accompanying report confirmed that the specific affected batches were not distributed or sold within China. Consequently, while a global recall was underway, no direct corrective actions or product retrieval efforts were required for the Chinese market regarding this particular incident.