FDA Device recall Z-0481-2014
Opal Orthodontics by Ultradent
- FDA Device
- Class III
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class III recall of Opal Orthodontics by Ultradent by Ultradent Products, citing ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0481-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-11-19 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ultradent Products |
| Distribution | US |
Product
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Reason
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Identifiers
| code_info | R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All Ultradent Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0481-2014%22
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