FDA Medical Device Recalls (openFDA)
Klowen Braces: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033
- Recall number
- Z-2699-2026
- Recalling firm
- Klowen Braces
- Product
- KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-07-08
- Terminated
- not on file
- Reason
- A product error defect may cause incorrect bracket placement.
- Root cause
- Process control
- Action
- KLOwen Orthodontics initially notified their consignees of the recall via telephone on 6/8/2026 and followed with a letter send certified mail on 6/16/2026. The notice explained the issue, potential risk which would arise from the use of the affected product and requested the following: "REQUIRED ACTIONS FOR YOUR PRACTICE 1 Assess the impact. Please review your inventory immediately to identify the affected KLOwen IDB trays and execute the following steps for unused trays. 2 Discard the affected tray to KLOwen. Do not proceed with bonding with the affected tray. Remove the tray from the case box and discard the tray into the trash. 3 Confirm disposal. Please sign this document confirming disposal of the tray. 4 Receive replacement tray. A correct replacement tray is in production and will be shipped to your practice as soon as it is completed. Your field representative will confirm the estimated ship date." The KLOwen field representative is the primary point of contact throughout this process and will keep customers informed of replacement timing and any additional actions needed.
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of OH, TX, SC VA.
- Lot, serial or model codes
- UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJJ
- Firm FEI
- 3030265369
- Firm city
- Richardson
- Firm state
- TX
- 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