China NMPA Product Recall - Powertrain

On August 16, 2016, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class I recall for specific batches of its Power System medical device, manufactured by Synthes GmbH. This recall was officially reported by the National Medical Products Administration (NMPA) on September 30, 2016. The primary issue identified was that the connecting cable of the Power System could generate excessive internal pressure and potentially explode, posing a serious risk of injury to both users and patients. Despite preliminary internal testing suggesting a low probability and no reported adverse events in China at the time, the company proceeded with the recall as a precautionary safety measure. Required actions included immediately notifying all affected distributors and hospitals globally to stop using and return the implicated products. The recalled devices were to be either destroyed locally or returned to the manufacturer.