ITS DUL and UOL Systems MRI Safety Recall - Class II

I.T.S. GmbH initiated a Class II medical device recall for its DUL and UOL orthopedic implant systems after post-market MRI safety testing demonstrated higher RF-induced heating than originally documented. The updated testing shows increased temperature rises under certain MRI conditions, requiring revision of the Instructions for Use safety information.\n\nHealthcare providers who perform MRI scans on patients with these implants must update their protocols and patient guidance. The recall affects orthopedic surgical facilities using Distal Ulna Locking and Ulna Osteotomy Locking systems. Facilities should distribute Field Safety Notices, update IFU documentation, and advise patients of potential MRI heating risks.