FDA Medical Device Recalls (openFDA)
Ultradent Products, Inc.: Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
- Recall number
- Z-0481-2014
- Recalling firm
- Ultradent Products, Inc.
- Product
- Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
- Status
- Terminated
- Initiated
- 2013-11-19
- Posted
- 2013-12-11
- Terminated
- 2014-10-06
- Reason
- Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 217 units
- Distribution
- Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
- Lot, serial or model codes
- R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJM
- Firm FEI
- 1718912
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28