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FDAJanuary 23, 2026device

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 L...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

i t s

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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