Official recall notice
FDA DeviceClass IINotable
FDA Recall: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
- Recall date
- 2026-07-15
- Brand
- Klowen Braces
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
A product error defect may cause incorrect bracket placement.
Product description
A product error defect may cause incorrect bracket placement.
Affected products
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0