Ultradent Products, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0876-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: February 8, 2013

Date Posted: March 6, 2013

Recall Number: Z-0876-2013

Event ID: 64303

Reason for Recall:

Orthodontic brackets distributed was incorrectly labeled.

Status: Terminated

Product Quantity: 124

Code Information:

Lot R131360

Distribution Pattern:

USA Nationwide Distribution including the states of CA, AZ, CO and WA.

Voluntary or Mandated:

Voluntary: Firm initiated