PlainRecalls
FDA Devices Low Class III Terminated

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.

Reported: March 6, 2013 Initiated: February 8, 2013 #Z-0876-2013

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.

Details

Recalling Firm
Ultradent Products, Inc.
Units Affected
124
Distribution
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Location
South Jordan, UT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Ultradent Products, Inc.. Units affected: 124.
Why was this product recalled?
Orthodontic brackets distributed was incorrectly labeled.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2013. Severity: Low. Recall number: Z-0876-2013.