China NMPA Product Recall - Mandibular unidirectional traction device

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its Mandibular Unidirectional Traction Device, as formally reported to the National Medical Products Administration (NMPA) on June 17, 2016. The recall was triggered by a significant manufacturing issue: fasteners on the device were found to prematurely separate from the proximal fixation plate. This defect presents serious patient risks, including the potential for prolonged surgery, the necessity for reoperation, and an increased likelihood of local infection, particularly given the device's application in the oral cavity for conditions like mandibular hypoplasia. Manufactured by Synthes GmbH, the affected products globally encompass various models and batch numbers. In China, 20 units of the device were imported. Johnson & Johnson specified that these 20 units were used exclusively as test samples and have since been consumed, thus no further direct corrective actions are required for these specific units within China. This voluntary action reflects the company's adherence to the NMPA's regulatory guidelines for ensuring medical device safety and quality.