Z-0481-2014Class III

Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended...

Name: Z-0481-2014 Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended...
Creator: Ultradent Products, Inc.
Published: 2013-11-19
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2013-11-19 / Terminated / root cause: manufacturing process

FDA source

Ultradent Products, Inc. began a recall of Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment on 2013-11-19. FDA classified it as Class III and gives the reason as "Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0481-2014
Classification: Class III
Status: Terminated
Initiated: 2013-11-19
Posted: 2013-12-11
Terminated: 2014-10-06
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.
Product code: NJM Bracket, Ceramic, Orthodontic
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 217 units
Distribution: Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
Product codes and lots: R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0481-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0481-2014	Class III	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-11

Product code NJM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)