Recall Z-0481-2014— Ultradent Products, Inc.
Class III · Terminated
Class III FDA medical device recall by Ultradent Products, Inc., initiated 2013-11-19, terminated 2014-10-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.. Reason: Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution..
- Recalling firm
- Ultradent Products, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-11-19
- Terminated
- 2014-10-06
- Firm location
- South Jordan, UT, United States
Product description
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Reason for recall
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Data sourced from openFDA. This site is unofficial and independent of the FDA.