Z-2699-2026Class II

KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033

Name: Z-2699-2026 KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033
Creator: Klowen Braces
Published: 2026-06-08
License: https://open.fda.gov/license/

Klowen Braces dba Klowen Orthodontics / initiated 2026-06-08 / Open, Classified / root cause: manufacturing process

FDA source

Klowen Braces began a recall of KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033 on 2026-06-08. FDA classified it as Class II and gives the reason as "A product error defect may cause incorrect bracket placement". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2699-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-07-08
Recalling firm: Klowen Braces dba Klowen Orthodontics
Product: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Product code: QJJ Indirect Bonding Tray
Reason for recall: A product error defect may cause incorrect bracket placement.
Root cause tag: manufacturing process
FDA 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 in commerce: 3 units
Distribution: US Nationwide distribution in the states of OH, TX, SC VA.
Product codes and lots: UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2699-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2699-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-08

Product code QJJ

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)