FDA Enforcement
Class II
Terminated
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Recall: Z-2477-2020
·
Reported July 8, 2020
Enforcement
- Recall Number
- Z-2477-2020
- Event ID
- 85468
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ortho Organizers, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 8, 2020
- Initiation Date
- April 2, 2019
- Classification Date
- June 30, 2020
- Termination Date
- March 24, 2022
- Address
- 1822 Aston Ave, N/A, Carlsbad, CA, 92008-7306, United States
Description
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Reason
Orthodontic Bracket is mislabeled
Code Info
Maestro Orthodontic Bracket REF711-206-10 (01)00190707016517 (10)112233 (422)484 LOT#s: 898430 & 888666
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
Quantity
104 packages