China NMPA Product Recall - Spinal fixation system

Pioneer Surgical Technology, Inc. initiated a voluntary Class III recall of its Spinal Fixation System (Registration No.: 20133462783) due to issues with the rod length not meeting specified requirements. This recall, reported to the National Medical Products Administration (NMPA), then CFDA, on December 27, 2016, affects 46 units imported into China, specifically batch number 202332.The recalled devices are non-cervical spine fixation systems, utilized as pedicle screw or anterior lateral fixation for various conditions including degenerative disc disease, vertebral anterior displacement, trauma, spinal deformities like scoliosis or kyphosis, spinal cord tumors, and stenosis, primarily in patients with matured bones. As part of the corrective actions, Pioneer Surgical Technology, Inc. formally notified its distributors via email to retrieve the affected batch of products. All identified units have been isolated to prevent further use, and the company is currently awaiting additional guidance and notifications from the manufacturer to resolve the issue comprehensively. This proactive measure underscores the company's commitment to patient safety and product integrity in adherence to regulatory standards.