Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Reported: December 18, 2013 Initiated: November 19, 2013 #Z-0481-2014
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.
Details
- Recalling Firm
- Ultradent Products, Inc.
- Units Affected
- 217 units
- Distribution
- Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.. Recalled by Ultradent Products, Inc.. Units affected: 217 units.
Why was this product recalled? ▼
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2013. Severity: Low. Recall number: Z-0481-2014.
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