North Coast Medical Inc recalls Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC…

Recall date

August 18, 2023

Source

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

Recall number

Z-0125-2024

FDA classification

Class II

Brand / firm

North Coast Medical Inc

Sold / distributed

US: NC, CA, WI OUS: New Zealand, Australia,

Why it was recalled

The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling.

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

What was recalled

Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-Large/Left), and NC86657 (X-Large/Right)