Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Avex CX Suite Recalled by Ultradent Products, Inc. Due to Orthodontic brackets distributed was incorrectly labeled.

Date: February 8, 2013
Company: Ultradent Products, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ultradent Products, Inc. directly.

Affected Products

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.

Quantity: 124

Why Was This Recalled?

Orthodontic brackets distributed was incorrectly labeled.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ultradent Products, Inc.

Ultradent Products, Inc. has 23 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report