Home / Recalls / Ultradent Products, Inc. / Z-0876-2013

Z-0876-2013 Class III Terminated

Recalled by Ultradent Products, Inc. — South Jordan, UT

Recall Details

Product Type
Devices
Report Date
March 6, 2013
Initiation Date
February 8, 2013
Termination Date
June 7, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
124

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.

Reason for Recall

Orthodontic brackets distributed was incorrectly labeled.

Distribution Pattern

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

Code Information

Lot R131360

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