Medical device recalls Moderate risk

TENNIS ELBOW SUPPORT recalled over mold contamination

Recall date
November 7, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
DeRoyal Industries Inc recalls TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epico…
Recall number
Z-0712-2017
FDA classification
Class II
Brand / firm
DeRoyal Industries Inc
Sold / distributed
US Nationwide Distribution

Why it was recalled

DeRoyal received complaints of mold on Tennis Elbow Straps.

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

What was recalled

TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis

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