I.T.S. GmbH device recall (Cls II)

Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4. — Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). — Status: Ongoing