FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH Radius Plate PROlock II recalled for inaccurate MRI safety labeling
What this means
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.
The agency's original wording
Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Intended for
Adults
Illnesses reported
None reported
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-1592-2026Want us to check the next one for you?
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