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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 3 Recall
Avex CX Suite		see related information
Date Posted February 22, 2013
Recall Number Z-0876-2013
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
Reason for
Recall		 Orthodontic brackets distributed was incorrectly labeled.
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.
 
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