FDA-Device2026-04-01Class IIMISBRANDING
I.T.S. GmbH FR.O.H. Calcaneus Repair System recalled for higher MRI heating risk
What this means
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
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
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-1595-2026Want 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.