The ICON Modular System is used by surgeons during back and spine surgery. The recall was prompted after reports of faulty screws and rods. The small pieces which hold the spine together during and sometimes after surgery were found to loosen during the post-operative period. It is possible that injury could occur due to the faulty parts.
4% of the patients with recalled ICON devices have reported problems and had the devices removed. Back surgery patients will be contacted if the recalled Blackstone Medical Inc. ICON Modular Fixation System was used.
