FDA Medical Device Recalls (openFDA)
Ultradent Products, Inc.: 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.
- Recall number
- Z-0876-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-02-08
- Posted
- 2013-02-22
- Terminated
- 2013-06-07
- Reason
- Orthodontic brackets distributed was incorrectly labeled.
- 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
- 124
- Distribution
- USA Nationwide Distribution including the states of CA, AZ, CO and WA.
- Lot, serial or model codes
- Lot R131360
- 510(k) numbers
- ["K922499"]
- PMA numbers
- not on file
- Product code
- EJF
- 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