TemporaryFDAOngoing
Can cause harm that is usually temporary.
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Check the device or its packaging for
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
- Why
- A product error defect may cause incorrect bracket placement.
- Distributed
- US Nationwide distribution in the states of OH, TX, SC VA.
- Company
- Klowen Braces
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2699-2026 · retrieved 8 July 2026
Read the official notice