FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. ulna bone plates and screws recalled for higher MRI heating
Check MRI safety for I.T.S. ulna bone implants
I.T.S. GmbH is recalling specific DUL and UOL bone plate and screw systems used to stabilize ulna fractures. New MRI safety testing found these implants generate more heat during MRI scans than the original instructions stated, which could potentially cause tissue damage.
- If you have one of these implants, inform your doctor before any MRI procedure.
- Do not have an MRI until you confirm with your surgeon whether your specific implant model is safe under current MRI conditions.
- Check the product article number and lot number on your implant documentation to see if yours is affected.
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
120 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1604-2026More 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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