FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH Radius Plate PROlock II recalled for inaccurate MRI safety labeling
OTHERNationwide distribution
Check MRI safety info for I.T.S. radius plates
I.T.S. GmbH's Radius Plate PROlock II (a surgical implant for wrist fractures) has been recalled because new MRI safety testing found the device heats up more than the instructions said it would under certain MRI scanner conditions. The original safety information in the product labeling did not reflect these higher temperature increases.
- If you have received this implant, contact your surgeon or orthopedic doctor before undergoing any MRI procedure.
- Do not proceed with an MRI until your doctor reviews the updated safety information with you.
- Ask your healthcare provider for the latest MRI safety guidance from I.T.S. GmbH for your specific implant.
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Sold states
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.
Affected count
220 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1592-2026More I.T.S. GmbH recalls
- FDA-Device2026-04-01I.T.S. GmbH headless compression screws recalled for increased MRI heating risk
- FDA-Device2026-04-01I.T.S. GmbH foot and hallux osteotomy locking plates recalled for MRI safety concerns
- FDA-Device2026-04-01I.T.S. GmbH olecranon plates recalled for MRI heating risk
- FDA-Device2026-04-01I.T.S. Screw System recalled for higher MRI-induced heating than labeled
- FDA-Device2026-04-01I.T.S. GmbH HLS Hand Locking Plates System recalled for higher MRI temperature risk
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