Official recall notice

FDA DeviceClass IINotable

FDA Recall: I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descr

Recall date
2026-04-01
FDA class
Class II

Why it was recalled

Hazard

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

Recommended action

What to do

120 units

Product description

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

Verify with the official notice →
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