China NMPA Product Recall - Artificial Vertebral System

Synthes GmbH, the manufacturer, in collaboration with its Chinese distributor, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of its Artificial Vertebral Body System (Registration No.: 20153462090). This recall, reported to the National Medical Products Administration (NMPA) on November 17, 2015, stemmed from a manufacturing issue: a potential missing prong on one side of certain devices (Model/Specification: 495.317). This prong is designed to enhance fixation during surgery. The primary concern is that a missing prong could theoretically reduce the device's resistance to implant displacement. However, the manufacturer assessed the likelihood of this issue causing increased overall implant displacement or patient injury as very small. The main anticipated consequences were slight surgical delays or user dissatisfaction, as the missing prong is detectable during use. To date, no patient injuries related to this defect have been reported. Under the NMPA's regulatory oversight, the document specifies that the affected product batch was manufactured in Germany and was not imported into or sold within China. Consequently, no direct corrective actions, such as product retrieval or patient-specific interventions, are required within China. The NMPA requested local food and drug administrations to reinforce supervision of similar products. For patients already implanted with this system, prophylactic removal is not recommended.