Reported Mar 6, 2013 · 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…

Ultradent Products, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ultradent Products, Inc. · 505 W 10200 S · South Jordan, UT · 84095-3935

Is this the product you have?

    • Avex CX Suite
    • Avex CX 0.22 UL4
    • 5 HK REF #224-017
  • Product UsageAvex 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 codes and dates
  • Lot R131360
Amount recalled
124

Where it was sold

Why it was recalled

Orthodontic brackets distributed was incorrectly labeled.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 7, 2013 · Data as of Sep 19, 5:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.