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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 Device Recall Opal Orthodontics by Ultradent see related information
Date Initiated by Firm November 19, 2013
Date Posted December 11, 2013
Recall Status1 Terminated 3 on October 06, 2014
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 UT 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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