ITS GmbH Recalls HLS Hand Locking Plates System Over MRI Temperature Hazards
Summary
FDA announced ITS GmbH's Class II recall of the HLS Hand Locking Plates System after updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than previously disclosed in Instructions for Use. The recall affects multiple cortical screw article numbers distributed nationwide across over 25 states.
What changed
ITS GmbH has amended its HLS Hand Locking Plates System recall status following new MRI safety testing that demonstrates higher RF-induced temperature increases during MRI procedures than previously reflected in the Instructions for Use. The affected products include multiple cortical screw article numbers (32151-6 through 32151-12 and additional variants) distributed nationwide.
Healthcare providers, hospitals, and surgical centers that have purchased or implanted these orthopedic devices must immediately review their inventory, update MRI safety protocols, and notify clinical staff about the revised temperature risk data. Patients with implanted HLS devices may require modified MRI screening procedures or alternative imaging methods under certain MRI conditions.
What to do next
- Identify and quarantine all affected HLS Hand Locking Plates System and Cortical Screw article numbers in inventory
- Update MRI safety protocols to reflect revised temperature increase data for patients with implanted HLS devices
- Notify all relevant clinical staff and radiology departments about the MRI temperature hazard update
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
I.T.S. GmbH
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1607-2026 · 20260401 · Ongoing
Product
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 3215...
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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