FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. Fibula Plate PROlock recalled for higher-than-expected MRI temperature increases
BURNNationwide distribution
Check MRI safety if you have I.T.S. fibula plate
I.T.S. GmbH fibula plates used in orthopedic surgery have been recalled because new MRI safety testing found they heat up more than the instructions originally stated when exposed to certain MRI machine conditions. This could potentially cause tissue burns during an MRI scan.
- If you had orthopedic surgery with an I.T.S. fibula plate, inform your doctor or surgeon before any MRI procedure
- Check your surgical records or implant card for the article and lot numbers listed in the recall
- Contact your surgeon or hospital to confirm whether your plate is affected and discuss MRI safety with your healthcare provider
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
869 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1601-2026More 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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