I.T.S. GmbH FR.O.H. Calcaneus Repair System Class II MRI Safety Recall
Summary
FDA issued Class II recall Z-1595-2026 for I.T.S. GmbH's FR.O.H. Calcaneus Repair System (Article Number 21064-60). Updated MRI safety testing revealed higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use. The device was distributed nationwide across multiple U.S. states.
What changed
I.T.S. GmbH initiated a Class II medical device recall for the FR.O.H. Calcaneus Repair System after updated MRI safety testing demonstrated higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use. The recall affects Anterolateral Calcaneus Plate Article Number 21064-60.
Healthcare providers using or prescribing this calcaneus plate system should immediately review the updated MRI safety information. Patients with implanted devices should be assessed for MRI compatibility under the new safety parameters. Medical device manufacturers should verify their MRI safety testing protocols remain current and adequate.
What to do next
- Review MRI safety labeling for FR.O.H. Calcaneus Repair System
- Assess current patients with implanted devices under MRI conditions
- Report any adverse events related to MRI heating to FDA
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
I.T.S. GmbH
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1595-2026 · 20260401 · Ongoing
Product
FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
Reason for Recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
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...
Source: openFDA Enforcement API
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