FDA-Device2020-07-08Class II

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

Ortho Organizers, Inc.
Hazard

Orthodontic Bracket is mislabeled

Sold states
13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic
Affected count
147 kits
Manufactured in
1822 Aston Ave, N/A, Carlsbad, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2478-2020

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