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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 Recall
Avex CX Suite
see related information
Date Posted February 22, 2013
Recall Status1 Terminated on June 07, 2013
Recall Number Z-0876-2013
Recall Event ID 64303
Premarket Notification
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/
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
Orthodontic brackets distributed was incorrectly labeled.
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
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 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.
510(K) Database 510(K)s with Product Code = EJF and Original Applicant = CDB CORP.
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