Official recall notice
FDA DeviceClass IINotable
FDA Recall: FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below description
- Recall date
- 2026-04-01
- Brand
- I.T.S. GmbH
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Recommended action
What to do
15,517 units
Product description
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).