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I.T.S. GmbH recalls Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 2103
Recalled April 1, 2026 · FDA recall Z-1592-2026 · I.T.S
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). · FDA Class II
Units
220 units
Sold at
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, SC, TX, USVI, WV, W.
Description
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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, 21035-3, 21036-3.
Manufacturer(s)
I.T.S. GmbH
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →