Z-0876-2013Class III

Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017

Name: Z-0876-2013 Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017
Creator: Ultradent Products, Inc.
Published: 2013-02-08
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2013-02-08 / Terminated / root cause: packaging

FDA source

Ultradent Products, Inc. began a recall of 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... on 2013-02-08. FDA classified it as Class III and gives the reason as "Orthodontic brackets distributed was incorrectly labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0876-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-08
Posted: 2013-02-22
Terminated: 2013-06-07
Recalling firm: Ultradent Products Inc.
Product: 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.
Product code: EJF Bracket, Metal, Orthodontic
Reason for recall: Orthodontic brackets distributed was incorrectly labeled.
Root cause tag: packaging
FDA 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 in commerce: 124
Distribution: USA Nationwide Distribution including the states of CA, AZ, CO and WA.
Product codes and lots: Lot R131360

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0876-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0876-2013	Class III	Terminated	Voluntary: Firm initiated	2013-03-06	2013-02-22

Product code EJF

K922499Class IReflections - Ceramic Dental BracketCdb Corp. / cleared 1992-07-30

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)