← FDA ENFORCEMENT
Z-2699-2026Class II
Klowen Braces
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Klowen Braces
Product type
Device
Status
Ongoing
Report date
2026-07-15
Distribution
US Nationwide distribution in the states of OH, TX, SC VA.
Firm state
TX
Product quantity
3 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change ControlReason for recall
A product error defect may cause incorrect bracket placement.
Product description
KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
Code / lot info
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Other recalls SPEQ maps to Documentation & Change Control
2026-09-02Class IIMidmark Corporation2026-09-02Class IIConMed Corporation2026-09-02Class IIAVID Medical, Inc.2026-09-02Class IIOlympus Corporation of the Americas
See all Documentation & Change Control recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →