FDA DeviceClass IINotable

FDA Recall: HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31

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

623 units

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