I.T.S. GmbH recalls I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Dista…

Recall date

January 23, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1603-2026

FDA classification

Class II

Brand / firm

I.T.S. GmbH

Sold / distributed

US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.