United Surgical Associates recalls Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lo…

Recall date

April 13, 2015

Source

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

Recall number

Z-1665-2015

FDA classification

Class II

Brand / firm

United Surgical Associates

Sold / distributed

Domestic: HI International; None

Why it was recalled

The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

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

What was recalled

Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.