FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. LRS orthopedic plates recalled for higher MRI heating than labeled
BURNNationwide distribution
Contact your surgeon about I.T.S. orthopedic plates
I.T.S. GmbH recalled certain distal femur and tibia locking plates used in orthopedic surgery after updated MRI safety testing found they produce higher temperature increases during MRI scans than the original instructions stated. This could potentially cause tissue heating at the implant site during an MRI procedure.
- If you have one of these implants, contact your surgeon or orthopedic clinic to discuss MRI safety before undergoing any MRI scan.
- Provide your surgeon with your implant article number and lot number if available.
- Do not have an MRI until you have discussed the updated safety information with your medical team.
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
176 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1603-2026More 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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