I.T.S. GmbH Headless Compression Screw MRI Safety Recall
Summary
FDA initiated a Class II recall (Z-1606-2026) for I.T.S. GmbH's Headless Compression Screw System due to updated MRI safety testing revealing higher RF-induced temperature increases under certain MRI conditions than previously documented in the Instructions for Use. The recall affects multiple article numbers distributed nationwide across multiple US states. Healthcare providers and distributors should immediately identify affected inventory and halt use pending updated guidance.
What changed
I.T.S. GmbH initiated a Class II medical device recall for its Headless Compression Screw System after updated MRI safety testing demonstrated that RF-induced temperature increases exceeded previously documented levels in the Instructions for Use under certain MRI conditions. The affected products include article numbers 31207-10 through 31207-30 and additional variants, distributed nationwide across states including AL, AZ, CA, CO, FL, GA, IL, and many others.\n\nHealthcare providers and distributors should immediately identify whether they hold affected inventory by article number, quarantine and stop using the device until updated MRI safety information is received, and notify relevant clinical staff of the recall. The recall is ongoing, and firms should monitor FDA updates for corrected Instructions for Use and further guidance on safe use during MRI procedures.
What to do next
- Identify affected HCS Headless Compression Screw System inventory by article number
- Quarantine and cease use of affected devices pending updated MRI safety guidance
- Notify relevant clinical staff of MRI safety concerns with this device
Source document (simplified)
I.T.S. GmbH
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1606-2026 · 20260401 · Ongoing
Product
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,...
Reason for Recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Distribution
US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA...
Source: openFDA Enforcement API
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