FDA Device recall Z-0876-2013
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
- FDA Device
- Class III
- terminated
- Published 2013-03-06
On 2013-03-06 the FDA classified a Class III recall of 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 by Ultradent Products, citing orthodontic brackets distributed was incorrectly labeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0876-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-08 |
| Published | 2013-03-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ultradent Products |
| Distribution | US |
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
Orthodontic brackets distributed was incorrectly labeled.
Identifiers
| code_info | Lot R131360 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Ultradent Products
- Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011
FDA Device · Class II · 2026-04-08 · Ultradent Products - Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number: 1203- Software Version: N/A Product Description: Vit…
FDA Device · Class II · 2024-09-18 · Ultradent Products - Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Descriptio…
FDA Device · Class II · 2024-09-18 · Ultradent Products - Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill 10pk Model/Catalog Number: 4757- Software Version: N/A Pro…
FDA Device · Class II · 2024-09-18 · Ultradent Products - Peak Universal Bond Self-Etch Bottle Kit, Part: 4541
FDA Device · Class II · 2022-07-20 · Ultradent Products
All Ultradent Products recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0876-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.