China NMPA Product Recall - Small electric systems

On December 22, 2014, the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration announced a Class III voluntary recall initiated by Synthes GmbH, with Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. acting as the responsible unit in China. The recall pertains to the Small Powered System (SED), model 05.001.175. The primary issue identified by the manufacturer is that the SED may exhibit critical fault modes, including complete device failure, operation exclusively in reverse, or unintended activation of the reverse mode. These malfunctions pose significant risks during surgical procedures. If the device fails during operation, it could lead to surgical delays as users seek replacements. More critically, unintended activation or incorrect operational modes could result in serious patient harm, such as bone/soft tissue injury, peripheral nerve injury, or vascular injury, potentially necessitating additional surgical or medical intervention. Although the product was imported into China, it was not sold within the country. The recall was enacted to mitigate potential risks associated with the faulty device. This action reflects the regulatory framework's commitment to patient safety, requiring immediate action when medical device defects are identified, even if the product has not entered the consumer market.