KL Owen Custom Orthodontic Solution, model/catalog number… recallZ-2699-2026 · Klowen Braces · initiated Jun 8, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Klowen Braces or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A product error defect may cause incorrect bracket placement.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2699-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 8, 2026
- Posted by the FDA
- Jul 8, 2026
- Recalling firm
- Klowen Braces
- Quantity
- 3 units
- Product code
- QJJ
- Distribution
- US Nationwide distribution in the states of OH, TX, SC VA.
Product description
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Code information (models, lots, serial numbers)
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Custom Orthodontic Solution CIAS-800033Klowen Braces, Inc. · Indirect Bonding Tray1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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