Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
- Company
- Ultradent Products, Inc.
- Recall Initiated
- November 19, 2013
- Posted
- December 11, 2013
- Terminated
- October 6, 2014
- Recall Number
- Z-0481-2014
- Quantity
- 217 units
- Firm Location
- South Jordan, UT
Reason for Recall
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
Distribution
Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
Lot / Code Info
R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
Root Cause
Process control
Action Taken
Ultradent Products notified consignees via email on November 19, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product. Sales representatives will pick up remaining unplaced brackets or returns will be sent back using pre-paid envelopes back to Ultradent recall coordinator for quarantine. Consignees were asked to complete evaluation forms to be returned by fax to 800-793-5206. For questions regarding this recall call 801-553-4420.