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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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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
Distribution Pattern USA Nationwide Distribution including the states of CA, AZ, CO and WA.

Product Detail

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