China NMPA Product Recall - Hip joint surgical instruments (product name: RECLAIM)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting on behalf of manufacturer DePuy (Ireland), initiated a voluntary recall for the RECLAIM hip surgical instrument (Registration Certificate No.: CFDA (Imported) 2014 No. 1100752). This action was publicly noted by the National Medical Products Administration (NMPA) on May 4, 2015, following a complaint received on February 6, 2015. The primary concern was the potential for the prosthesis implant adapter (model: 2975-00-920) to break during hip replacement surgery, potentially leaving fragments within the patient. An investigation corroborated this risk. Under the NMPA's regulatory framework, Johnson & Johnson (Shanghai) reported the incident. Crucially, the affected product batches were neither imported into nor sold within China, with distribution limited to regions such as Ireland, Iceland, and the USA. Consequently, no further specific corrective actions, such as additional investigations or implementation plans, were required from Johnson & Johnson (Shanghai) within China. However, the NMPA requested that provincial food and drug administrations strengthen their oversight and management of similar medical devices.