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KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,

Class II
Recalling firm
Klowen Braces
Reason for recall
A product error defect may cause incorrect bracket placement.
Affected products (lot / model / serial)
UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
Units affected
3 units
Distribution pattern
US Nationwide distribution in the states of OH, TX, SC VA.
Firm location
Richardson, TX, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Telephone
Product type
Devices
Status
Ongoing
Recall number
Z-2699-2026
Recall initiated
June 8, 2026
FDA classification date
July 8, 2026
FDA report date
July 15, 2026
FDA event ID
99277
Last updated on HTM Vibe
July 23, 2026
View on openFDA