I.T.S. calcaneus repair plate heats more in MRI than stated
I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System anterolateral calcaneus plate because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.
- Product
- FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
- Category
- Medical Device
- Distribution
- Distributed nationwide