ITS Volar Radius Plate PROlock II MRI Safety Recall
Summary
I.T.S. GmbH issued a Class II medical device recall for its Volar Radius Plate PROlock II (Article Numbers 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, and others). Updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than previously disclosed in the Instructions for Use (IFU). The recall affects products distributed nationwide across multiple US states.
What changed
I.T.S. GmbH updated its MRI safety testing data for the Volar Radius Plate PROlock II, revealing that RF-induced temperature increases under certain MRI conditions are higher than previously reflected in the product's Instructions for Use. This discrepancy means healthcare providers and patients relying on the original IFU may have incomplete information regarding MRI safety risks.
Healthcare providers using or considering this orthopedic plate should verify which article numbers are in their inventory and contact I.T.S. GmbH for corrected IFU. MRI facilities should update scanning protocols and patient safety assessments accordingly, as the higher RF heating profile may affect scan eligibility or require modified scan parameters for patients with these implants.
What to do next
- Review MRI safety labeling for affected Volar Radius Plate PROlock II article numbers
- Contact I.T.S. GmbH for updated Instructions for Use
- Assess MRI protocols for patients with implanted devices
Archived snapshot
Apr 11, 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-1592-2026 · 20260401 · Ongoing
Product
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5,...
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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