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
Z-2478-2020
Product summary
- Event
- Event 85468
- Status
- Terminated
- Classification
- Class II
- Quantity
- 147 kits
- Official record key
device-enforcement:Z-2478-2020
Official wording
Reason: Orthodontic Bracket is mislabeled
Code information: Maestro Orthodontic Bracket ,.018 Kit U/L SxS P/N711-298Q (01)00190707017064 (10)889437 (422)484 Lot# 878285 Maestro Orthodontic Bracket .018 Kit U/L SxS MC Hooks P/N711-299MCQ UDI (01)00190707017071(10)889437 (422)484 Lot#872900
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