I.T.S. clavicle plates heat more in MRI than instructions state
I.T.S. GmbH is recalling Clavicula Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.
- Product
- Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article
- Category
- Medical Device
- Distribution
- Distributed nationwide