Recall Z-1595-2026— I.T.S. GmbH

Name: FDA recall Z-1595-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-23

Class II · Ongoing

Class II FDA medical device recall by I.T.S. GmbH, initiated 2026-01-23. It names one FDA 510(k) clearance: K051642. Product: 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)..

Recalling firm: I.T.S. GmbH
Classification: Class II
Status: Ongoing
Initiated: 2026-01-23
Firm location: Lasnitzhohe, Austria

510(k) clearances named in this recall

1 on FDA's record

K051642 — FR.O.H. CALCANEUS REPAIR SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH·cleared 2005-08-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.