Recall Z-0876-2013 ยท EJF Bracket, Metal, Orthodontic
Ultradent Products, Inc.
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.
| Date | Feb 22, 2013 (initiated Feb 8, 2013) |
| Status | Terminated |
| Reason | Orthodontic brackets distributed was incorrectly labeled. |
| Root cause | Packaging |
| Action | Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 8 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to return affected products for replacement. Customers with questions can call firm representative, Corey Jaseph at (801) 553-4220. |
| Quantity | 124 |
| Distribution | USA Nationwide Distribution including the states of CA, AZ, CO and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET Cdb Corp., Jul 30, 1992 |