ITS Fibula Plate PROlock Recall Due to MRI Temperature Risk

FDA Class II recall Z-1601-2026 was issued for I.T.S. GmbH Fibula Plate PROlock devices after updated MRI safety testing demonstrated higher RF-induced temperature increases under certain MRI conditions than previously disclosed in product Instructions for Use. The recall affects multiple distal tubular plate article numbers distributed nationwide across multiple states.\n\nHealthcare providers, hospitals, and surgical facilities using these orthopedic devices must immediately identify affected inventory, quarantine products, and review MRI safety protocols for patients who may have been exposed to elevated RF temperatures during imaging procedures. The recall remains ongoing with no specific completion date stated.