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U.S. Department of Health and Human Services

Class 3 Device Recall Avex CX Suite

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  Class 3 Device Recall Avex CX Suite see related information
Date Initiated by Firm February 08, 2013
Date Posting Updated February 22, 2013
Recall Status1 Terminated 3 on June 07, 2013
Recall Number Z-0876-2013
Recall Event ID 64303
510(K)Number K922499  
Product Classification Bracket, metal, orthodontic - Product Code EJF
Product Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017,

Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.
Code Information Lot R131360
Recalling Firm/
Ultradent Products, Inc.
505 W 10200 S
South Jordan UT 84095-3935
For Additional Information Contact Corey Jaseph
Manufacturer Reason
for Recall
Orthodontic brackets distributed was incorrectly labeled.
FDA Determined
Cause 2
Action Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 8 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to return affected products for replacement. Customers with questions can call firm representative, Corey Jaseph at (801) 553-4220.
Quantity in Commerce 124
Distribution USA Nationwide Distribution including the states of CA, AZ, CO and WA.
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.
510(K) Database 510(K)s with Product Code = EJF and Original Applicant = CDB CORP.