FDA-Device2026-04-01Class IIMISBRANDING

I.T.S. ulna bone plates and screws recalled for higher MRI heating

I.T.S

BURNOTHERNationwide distributionMedical devices

What this means

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.

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

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-1604-2026

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.