China NMPA Product Recall - Spinal fixation system

Pioneer Surgical Technology, Inc. initiated a voluntary Class III recall for its Spinal Fixation System (CFDA 2013 No. 3462783). This action, reported on December 2, 2016, and published by the National Medical Products Administration (NMPA) on January 5, 2017, was prompted by the rod length of the device not meeting specified requirements. The affected product, model 10-55-RH-400, with lot number 202332, involves 46 units produced and sold in China. This system is intended for non-cervical spine fixation, addressing conditions like degenerative disc disease, trauma, and spinal deformities in patients with mature bones. As part of the corrective actions, the company formally notified distributors via email to retrieve the specific batch of products. Distributors were instructed to isolate all affected inventory and await further guidance from the manufacturer. Antaikang (Beijing) Consulting Co., Ltd. acted as the responsible unit in China, overseeing these recall procedures in adherence to NMPA regulatory standards.