Device product
Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
Z-0876-2013
Product summary
- Event
- Event 64303
- Status
- Terminated
- Classification
- Class III
- Quantity
- 124
- Official record key
device-enforcement:Z-0876-2013
Official wording
Reason: Orthodontic brackets distributed was incorrectly labeled.
Code information: Lot R131360
Distribution pattern: USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Derived failure modes
-
Labeling or packaging
incorrectly labeled