FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH Pilonplate with Angular Stability recalled for MRI safety concern
BURNNationwide distribution
Contact your doctor about I.T.S. GmbH Pilonplate
I.T.S. GmbH has recalled certain Pilonplate devices used in orthopedic surgery because new MRI safety testing found they heat up more than expected during MRI scans under certain conditions. The devices affected include Anterolateral Tibia Plates, Pilon Plates 4mm, and Pilon Plates Small with specific article and lot numbers.
- If you have had surgery with one of these plates, contact your surgeon or orthopedic doctor with your implant information
- Do not have an MRI scan until you speak with your doctor about your implant
- Ask your doctor about your implant's specific article and lot number to determine if it 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
101 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1596-2026More 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief