China NMPA Product Recall - Anterior cervical spine fixation system (trade name: Skyline)

This National Medical Products Administration (NMPA) document, published on July 4, 2017, details a Class II voluntary recall initiated by Medos International SARL for its Anterior Cervical Fixation System (Registration Certificate No.: CFDA (Imported) 2014 No. 3464098). The recall was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., the product's agent in China, on May 19, 2017. The primary issue prompting the recall is a potential packaging discrepancy. Specifically, packaging bags intended for variable screws of the cervical fixation system might inadvertently contain fixed screws. This mislabeling could lead to incorrect device usage during surgical procedures, posing a potential patient safety risk. The affected products include various models and lengths of both variable and fixed self-drilling/tapping and large diameter screws, all under the Skyline trade name. Under the NMPA's regulatory oversight for medical devices, Medos International SARL is undertaking this voluntary recall action. However, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. confirmed that no affected products from the identified batches were imported or sold within China. Consequently, no specific corrective actions are required for the Chinese market. The purpose of this report is to officially communicate the recall status to the relevant regulatory bodies.