Medical device recalls Moderate risk

Maestro Orthodontic Bracket REF711 QTY recalled over labeling errors

Recall date
April 2, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Ortho Organizers, Inc. recalls Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Recall number
Z-2477-2020
FDA classification
Class II
Brand / firm
Ortho Organizers, Inc.
Sold / distributed
13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic

Why it was recalled

Orthodontic Bracket is mislabeled

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

What was recalled

Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484

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