Opal Orthodontics by Ultradent — Class III medical device recall Z-0481-2014
Terminated recall by Ultradent Products, Inc., reported 2013-12-18, distributed nationwide. Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control
| Recall number | Z-0481-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultradent Products, Inc., South Jordan, UT, United States |
| Recall initiated | 2013-11-19 |
| Classified | 2013-12-11 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2014-10-06 |
| Distributed | Nationwide (US) |
| Quantity | 217 units |
| Lot numbers | 4519, 4522, 4524, 4527, 4530, 4534, 4537, 4548, 4550, 4554, 4558, 4612, 4618, 4624 |
Product
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Reason for recall
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0481-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.