FDA DeviceClass IINotable

FDA Recall: I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous

Date: 2026-04-01
Brand: I.T.S. GmbH
Category: Medical Device
FDA Class: Class II

Description

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Hazard

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Remedy

5,568 units

View original recall →
Share:

Related Recalls

2026-04-01 · FDA_DEVICE
FDA Recall: Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Hume
I.T.S. GmbH
2026-04-01 · FDA_DEVICE
FDA Recall: Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers.
I.T.S. GmbH
2026-04-01 · FDA_DEVICE
FDA Recall: I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article num
I.T.S. GmbH
2026-04-01 · FDA_DEVICE
FDA Recall: I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descr
I.T.S. GmbH