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Ultradent Products, Inc. recalls Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9%
Recalled March 6, 2013 · FDA recall Z-0876-2013 · Ultradent Products
Hazard
Orthodontic brackets distributed was incorrectly labeled. · FDA Class III
Units
124
Sold at
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Description
Orthodontic brackets distributed was incorrectly labeled.
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.
Manufacturer(s)
Ultradent Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →