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FDAFDA · Food and drugs·Recall number Z-2478-2020

Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

Published July 8, 2020 · Recall initiated: April 2, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Orthodontic Bracket is mislabeled

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Ortho Organizers, Inc.
Distributor
13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic
Lot
Maestro Orthodontic Bracket ,.018 Kit U/L SxS P/N711-298Q (01)00190707017064 (10)889437 (422)484 Lot# 878285 Maestro Orthodontic Bracket .018 Kit U/L SxS MC Hooks P/N711-299MCQ UDI (01)00190707017071(10)889437 (422)484 Lot#872900
Risk classification
Class II
Area (FDA)
device
Country
United States

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