China NMPA Product Recall - Hip replacement system

Smith & Nephew Orthopaedics Ltd. has initiated a voluntary Class III recall for its hip replacement system, as detailed in a report submitted to the National Medical Products Administration (NMPA) on May 8, 2017, and published on June 29, 2017. The manufacturer, with distribution handled by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., identified a critical manufacturing defect. The primary issue involves the incorrect assembly of the steel cable within the system, which prevents the cable from being properly attached to the implant. This functional impairment is particularly relevant when using curved or eccentric acetabular cup implants during a hip replacement procedure, potentially hindering surgical assembly and patient outcomes. The recall specifically targets affected product models and specifications, including 74120156, 74122162, and various 16FW series batch numbers. Although this recall is managed under the NMPA framework, the company's report explicitly confirms that zero affected products were sold or distributed in China, meaning the recall does not impact the Chinese market. The scope of the recall primarily involves regions such as Switzerland, Germany, the UK, and Italy. This proactive corrective action aims to mitigate risks associated with the assembly flaw, upholding product integrity and patient safety in the relevant international markets.