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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description 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.
Recall Number Z-0876-2013
Classification Class III
Code Info Lot R131360
Product Distributed Qty 124
Reason For Recall Orthodontic brackets distributed was incorrectly labeled.

Event Detail

Event Id 64303
Product Type Devices
Status Ongoing
Recalling Firm Ultradent Products, Inc.
City South Jordan
State UT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution including the states of CA, AZ, CO and WA.