FDA recall Z-2478-2020

Ortho Organizers, Inc. · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2019-04-02
Report date
2020-07-08
Termination date
2022-03-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carlsbad, CA, United States

Primary source

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