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Urgent Enforcement Added Final

I.T.S. GmbH Headless Compression Screw MRI Safety Recall

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Filed April 1st, 2026
Detected April 7th, 2026
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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

  1. Identify affected HCS Headless Compression Screw System inventory by article number
  2. Quarantine and cease use of affected devices pending updated MRI safety guidance
  3. 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

Named provisions

MRI Safety Instructions for Use (IFU)

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1606-2026

Who this affects

Applies to
Healthcare providers Medical device makers Importers and exporters
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Safety MRI Safety
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Public Health Healthcare

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