Device product
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Z-0481-2014
Product summary
- Event
- Event 66978
- Status
- Terminated
- Classification
- Class III
- Quantity
- 217 units
- Official record key
device-enforcement:Z-0481-2014
Official wording
Reason: Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Code information: R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
Distribution pattern: Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
Derived failure modes
-
Unknown
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.