Recall Z-1600-2026— I.T.S. GmbH

Name: FDA recall Z-1600-2026
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: K063166. Product: Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.. 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

K063166 — I.T.S. PELVIC RECONSTRUCTION SYSTEMI.T.S. Implantat-Technologie-Systeme GmbH·cleared 2006-12-22

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

Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.

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.