FDAFDA · Food and drugs·Recall number Z-0481-2014
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Published December 18, 2013 · Recall initiated: November 19, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultradent Products, Inc.
- Distributor
- Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
- Lot
- R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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