FDA Recall: FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Artic

Recall date: 2026-04-01
Brand: I.T.S. GmbH
Category: Medical Device
FDA class: Class II

Why it was recalled

Hazard

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Recommended action

What to do

4 units

Product description

Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Verify with the official notice →

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