I.T.S. pelvic reconstruction screws heat more in MRI than stated
I.T.S. GmbH is recalling the Pelvic Reconstruction System fixation screw and short spike because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.
- Product
- Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
- Category
- Medical Device
- Distribution
- Distributed nationwide