Medical device recalls Moderate risk

DeRoyal Industries Inc recalls DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

Recall date
November 21, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0706-2020
FDA classification
Class II
Brand / firm
DeRoyal Industries Inc
Sold / distributed
Nationwide, Australia, India, Saudi Arabia

Why it was recalled

The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.

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

What was recalled

DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP

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