FDA recall Z-2477-2020

Ortho Organizers, Inc. · Class II · device

Product

Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (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-2477-2020