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U.S. Department of Health and Human Services

Class 3 Device Recall Opal Orthodontics by Ultradent

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 Class 3 Recall
Opal Orthodontics by Ultradent
see related information
Date Posted December 11, 2013
Recall Status1 Open
Recall Number Z-0481-2014
Recall Event ID 66978
Product Classification Bracket, Ceramic, Orthodontic - Product Code NJM
Product Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Code Information R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
Recalling Firm/
Manufacturer
Ultradent Products, Inc.
505 W 10200 S
South Jordan, Utah 84095-3935
For Additional Information Contact Corey Jaseph
801-553-4420
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Ultradent Products notified consignees via email on November 19, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product. Sales representatives will pick up remaining unplaced brackets or returns will be sent back using pre-paid envelopes back to Ultradent recall coordinator for quarantine. Consignees were asked to complete evaluation forms to be returned by fax to 800-793-5206. For questions regarding this recall call 801-553-4420.
Quantity in Commerce 217 units
Distribution Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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