China NMPA Product Recall - Interbody fusion system

Pioneer Surgical Technology, Inc. initiated a voluntary Class III recall of its interbody fusion system in China, as reported to the National Medical Products Administration (NMPA) on December 20, 2016, and published on December 30, 2016. The recall stems from an internal discovery during a routine inspection, revealing an error in the sterilization expiration date on the outer labels of affected product batches. The labels incorrectly displayed an expiration date one to four months later than the actual date. The interbody fusion systems, registered under NMPA Certificate No. 20163462238, are intended for spinal interbody fusion procedures. As a corrective action, Pioneer Surgical Technology, Inc. instructed its domestic general distributor, Jietong Emego (Beijing) Pharmaceutical Technology Co., Ltd., to collect all unused affected products. The distributor is required to re-affix correct labels, provided by the manufacturer, onto the outer packaging of these devices without compromising the primary sterile packaging. This NMPA-guided action ensures accurate product information for patient safety and regulatory compliance.