Recall Z-1594-2026— I.T.S. GmbH

Name: FDA recall Z-1594-2026
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: K051412. Product: Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.. 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

K051412 — HUMERAL HEAD PLATE WITH ANGULAR STABILITYI.T.S. Implantat-Technologie-Systeme GmbH·cleared 2005-07-11

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

Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.

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.