I.T.S. HCS Headless Compression Screw Recall
HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31207-14, 31207-16, 31
Updated January 23, 2026
I.T.S. GmbH's HCS Headless Compression Screw System may heat up more than expected during MRI scans. The manufacturer has updated safety information to reflect higher temperature risks under certain MRI conditions.
Is the I.T.S. GmbH recalled? Yes. This product was recalled by FDA on January 23, 2026. Details below.
What is recalled
I.T.S. GmbH HCS Headless Compression Screw System, 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, 31307-32, 31307-34, 31307-36, 31307-38, 31358-30, 31437-30, 31437-38, 31437-40, 31437-50, 31757-45, 31757-80, 31757-85, 31757-90, 31757-100, and 31757-120.
Am I affected
You are affected if you have received one of these cannulated headless compression screws implanted. Check your surgical or implant documentation for the article number listed above. If you have an MRI scheduled, inform your healthcare provider of your implant article number before the procedure.
What to do right now
If you have one of these screws implanted and are scheduled for an MRI, contact your surgeon or the facility performing the MRI with your article number before your appointment. Do not delay, MRI safety is critical with implanted devices.
The hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Brands affected
- Source
- FDA
- Category
- Medical Devices
- Recall ID
- fda-Z-1606-2026
- Classification
- Class II
- Recalled
- January 23, 2026
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