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I.T.S. Headless Compression Screw System
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MEDICAL DEVICE RECALLMODERATE

I.T.S. Headless Compression Screw System

I.T.S. is recalling its Headless Compression Screw System due to higher-than-expected temperature increases during certain MRI conditions.

What to do

Contact your healthcare provider or facility to ensure the updated MRI safety information is documented in your medical records and that the updated Instructions for Use are followed for any future MRI procedures.

Posted
Updated
Recall No.
Z-1606-2026
Agency
Firm
I.T.S. GmbH
Recall ID
98341
Status
ONGOING

Why it was recalled

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

How to identify it

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31207-18, 31207-20, 31207-24, 31207-26, 31207-28, 31207-30, 31257-12, 31257-14, 31257-16, 31257-18, 31257-20, 31257-22, 31257-24, 31257-28, 31257-30, 31307-18…

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification