FDAFDA · Food and drugs·Recall number Z-0876-2013
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.
Published March 6, 2013 · Recall initiated: February 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Orthodontic brackets distributed was incorrectly labeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ultradent Products, Inc.
- Distributor
- USA Nationwide Distribution including the states of CA, AZ, CO and WA.
- Lot
- Lot R131360
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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