FDA Enforcement
Class II
Ongoing
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Recall: Z-1595-2026
·
Reported April 1, 2026
Enforcement
- Recall Number
- Z-1595-2026
- Event ID
- 98341
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- I.T.S. GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- April 1, 2026
- Initiation Date
- January 23, 2026
- Classification Date
- March 20, 2026
- Address
- Autal 28, Lasnitzhohe, N/A, Austria
Description
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Reason
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Code Info
Article Number (Lot Numbers): 21064-60 (679/012318, 679/0722100).
Distribution
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.
Quantity
4 units