Z-0876-2013 Class III Terminated
FDA device recall Z-0876-2013 was initiated by Ultradent Products, Inc. on February 8, 2013 and is designated Class III. Reason for recall: Orthodontic brackets distributed was incorrectly labeled. The recall status is terminated (terminated June 7, 2013). Affected quantity: 124.
Recall Details
- Product Type
- Devices
- Report Date
- March 6, 2013
- Initiation Date
- February 8, 2013
- Termination Date
- June 7, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 124
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.
Distribution Pattern
USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Code Information
Lot R131360