ITS GmbH Forearm Plates Recalled for MRI Safety Hazards

FDA issued a Class II medical device recall for I.T.S. GmbH Straight Forearm Plates with Angular Stability after updated MRI safety testing demonstrated higher RF-induced temperature increases than previously reflected in the Instructions for Use. The recall affects specific article numbers including Forearm Plate Curved (21604-6, 21604-9) and Forearm Plate Straight variants distributed nationwide across multiple US states.

Healthcare providers who have performed implant procedures or who manage patients with these devices should immediately review MRI safety protocols and update patient counseling materials. Facilities must assess whether current IFU documentation reflects the corrected safety data and implement appropriate clinical safeguards for patients requiring MRI imaging. The recall underscores the importance of post-market surveillance in identifying emerging safety signals for implanted devices.