China NMPA Product Recall - Interbody fusion system

Pioneer Surgical Technology, Inc. initiated a voluntary Class III recall of its interbody fusion system, as reported by the National Medical Products Administration (NMPA) on December 30, 2016. The issue was discovered during a routine inspection by Jietong Emego (Beijing) Pharmaceutical Technology Co., Ltd., the responsible unit in China. The main violation identified was inaccurate sterilization expiration dates printed on the outer labels of affected product batches. These labels incorrectly displayed expiration dates that were one to four months later than the actual expiration dates. The affected products, bearing National Medical Device Registration Certificate No. 20163462238, are used for interbody fusion in the cervical and thoracolumbar spine and were distributed within China. Specific models and batch numbers were impacted, including various configurations of 30-C-1012-6, 30-C-1214-6, and 30-T-1027-11. Under the NMPA's regulatory framework, Pioneer Surgical Technology, Inc. was required to take corrective actions. This involved sending a formal letter to the domestic general distributor, instructing them to collect all unused affected products. The distributor was then tasked with re-affixing new labels, incorporating the correct expiration information provided by the manufacturer. Importantly, this relabeling process was to be performed without opening the product's primary packaging, thus maintaining sterility. This recall ensures that medical professionals and patients receive products with accurate shelf-life information, mitigating potential risks associated with expired sterile devices.