Klowen Braces: Indirect Bonding Tray
Recall Summary Klowen Braces is recalling its KL Owen Custom Orthodontic Solution indirect bonding trays (model CIAS-800033) due to a product defect that may result in brackets being placed incorrectly on teeth. This Class I recall affects units distributed nationwide. Patients who received orthodontic treatment using these trays should contact their orthodontist to determine if their treatment was affected.
- Recalling firm
- Klowen Braces
- Product
- KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
- Reason
- A product error defect may cause incorrect bracket placement.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of OH, TX, SC VA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7348524d-4898-48ae-ac3d-76de4d673644