China NMPA Product Recall - Battery box

The National Medical Products Administration (NMPA) announced a voluntary recall initiated by Stryker Instruments, distributed in China by Stryker (Beijing) Medical Devices Co., Ltd., reported on February 2, 2015. The recall addresses defective battery cases for small battery-powered bone-powered handphones (CFDA Reg. No. 2014 No. 2102218) and bone-powered systems (CFDA Reg. No. 2014 No. 2102800). The core issue involves specific batches (13205, 13209, 13210, 13212) where the laser welding process failed to create a continuous bond layer in the battery cases. This manufacturing flaw can lead to separation of the battery box components, potentially causing surgical delays or a loss of device control during medical procedures. Such failures pose risks of complications, including the need for additional anesthesia, fractures, soft tissue injury, or infection. Under the NMPA's regulatory oversight, the immediate required actions are to discontinue use of all affected battery boxes and return them to the factory. It was specified that while these products were registered in China, they were not sold there, thus precluding a widespread local recall plan for distributed units within the country. Provincial food and drug administrations were requested to enhance their supervision of similar products.