FDAHealthJanuary 23, 2026
I.T.S. GmbH — FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
⚠️ Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 23, 2026
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.
What's affected?
- Product
- FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
- Brand
- I.T.S. GmbH
- Lot code
- ):
Additional details
Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100).
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4 units.
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