Avex CX Suite — Class III medical device recall Z-0876-2013
Terminated recall by Ultradent Products, Inc., reported 2013-03-06, distributed nationwide. Orthodontic brackets distributed was incorrectly labeled.
| Recall number | Z-0876-2013 |
|---|---|
| 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 | 2013-02-08 |
| Classified | 2013-02-22 |
| Reported by FDA | 2013-03-06 |
| Terminated | 2013-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 124 |
| Reason classes | labeling |
| Lot numbers | R131360 |
| Model numbers | 224-017 |
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.
Reason for recall
Orthodontic brackets distributed was incorrectly labeled.
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-0876-2013. 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.