China NMPA Product Recall - Interbody fusion system

Pioneer Surgical Technology, Inc. initiated a voluntary Class III recall of its Interbody Fusion System, as publicly reported on December 30, 2016, to the National Medical Products Administration (NMPA). This action stemmed from a routine inspection that uncovered an error where the sterilization expiration date on the outer labels of certain product batches was incorrectly marked, appearing 1-4 months later than the actual expiration date. The affected medical devices, registered under NMPA certificate 20163462238, were distributed in China and include models such as 30-C-1012-6, 30-C-1214-6, and 30-T-1027-11. The manufacturer's Chinese responsible unit, Jietong Emego (Beijing) Pharmaceutical Technology Co., Ltd., was tasked with managing the recall process. The required action involves Jietong Emego collecting all unused affected products from the market. Subsequently, they are responsible for re-affixing new labels with the correct sterilization expiration dates to the outer packaging, without compromising the inner product sterility. This corrective measure ensures accurate product information and adherence to patient safety standards under NMPA regulatory oversight.