Home / Recalls / Ortho Organizers, Inc. / Z-2478-2020

Z-2478-2020 Class II Terminated

Recalled by Ortho Organizers, Inc. — Carlsbad, CA

Recall Details

Product Type: Devices
Report Date: July 8, 2020
Initiation Date: April 2, 2019
Termination Date: March 24, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 147 kits

Product Description

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

Reason for Recall

Orthodontic Bracket is mislabeled

Distribution Pattern

13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic

Code Information

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