FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH FR.O.H. Calcaneus Repair System recalled for higher MRI heating risk
BURNNationwide distribution
Contact your surgeon about I.T.S. calcaneus plate
I.T.S. GmbH's FR.O.H. Calcaneus Repair System (anterolateral calcaneus plate, Article Number 21064-60) may heat more than expected during MRI scans under certain conditions. New testing found higher radiofrequency-induced temperature increases than the original instructions stated. Only 4 units were distributed nationwide.
- Contact the surgeon or facility where your calcaneus plate was implanted
- Ask about MRI safety precautions or alternative imaging options before any MRI procedure
- Request updated device instructions from your healthcare provider if you have this plate
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
4 units
Manufactured in
Autal 28, Lasnitzhohe, Austria
Products
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1595-2026More 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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