← FDA ENFORCEMENT
Z-2699-2026Class II

Klowen Braces

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 Control
Reason 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

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Data: U.S. FDA openFDA enforcement API. 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.