Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017 recallZ-0876-2013 · Ultradent Products, Inc. · initiated Feb 8, 2013
Class III Terminated All recalls posted in February 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ultradent Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Orthodontic brackets distributed was incorrectly labeled.
FDA root cause category: Packaging
What the company is doing
Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 8 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to return affected products for replacement. Customers with questions can call firm representative, Corey Jaseph at (801) 553-4220.
Recall details
- Recall number
- Z-0876-2013
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Feb 8, 2013
- Posted by the FDA
- Feb 22, 2013
- Recalling firm
- Ultradent Products, Inc.
- Quantity
- 124
- Product code
- EJF
- FDA submissions
- K922499
- Distribution
- USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Product description
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.
Code information (models, lots, serial numbers)
Lot R131360
Other devices under the same FDA submission
1 device cleared under K922499 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Reflections REF-571Ortho Technology, Inc. · Bracket, ceramic, orthodontic1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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