Class III — Low Risk

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

Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex Recalled by Ultradent Products, Inc. Due to Ultradent Products Inc. is recalling various lots of...

Date: November 19, 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

Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.

Quantity: 217 units

Why Was This Recalled?

Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.

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