Device product
Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484
Z-2477-2020
Product summary
- Event
- Event 85468
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104 packages
- Official record key
device-enforcement:Z-2477-2020
Official wording
Reason: Orthodontic Bracket is mislabeled
Code information: Maestro Orthodontic Bracket REF711-206-10 (01)00190707016517 (10)112233 (422)484 LOT#s: 898430 & 888666
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
Derived failure modes
-
Labeling or packaging
mislabeled