Recall Z-1601-2026— I.T.S. GmbH

Name: FDA recall Z-1601-2026
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: K063672. Product: I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.. 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

K063672 — FIBULA PLATE PROLOCK WITH ANGULAR STABILITYI.T.S. Implantat-Technologie-Systeme GmbH·cleared 2007-02-02

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

I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.

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.