Class 2 Device Recall KL Owen

• Date Initiated by Firm: June 08, 2026
• Date Posted: July 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2699-2026
• Recall Event ID: 99277
• Product Classification: Indirect bonding tray - Product Code QJJ
• Product: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
• Code Information: UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0
• FEI Number: 3030265369
• Recalling Firm/ Manufacturer: Klowen Braces; 1900 Firman Dr Ste 800; Richardson TX 75081-6769
• For Additional Information Contact: Nichole Leahy-Glass; 737-265-5220
• Manufacturer Reason for Recall: A product error defect may cause incorrect bracket placement.
• FDA Determined Cause: Process control
• Action: KLOwen Orthodontics initially notified their consignees of the recall via telephone on 6/8/2026 and followed with a letter send certified mail on 6/16/2026. The notice explained the issue, potential risk which would arise from the use of the affected product and requested the following: "REQUIRED ACTIONS FOR YOUR PRACTICE 1 Assess the impact. Please review your inventory immediately to identify the affected KLOwen IDB trays and execute the following steps for unused trays. 2 Discard the affected tray to KLOwen. Do not proceed with bonding with the affected tray. Remove the tray from the case box and discard the tray into the trash. 3 Confirm disposal. Please sign this document confirming disposal of the tray. 4 Receive replacement tray. A correct replacement tray is in production and will be shipped to your practice as soon as it is completed. Your field representative will confirm the estimated ship date." The KLOwen field representative is the primary point of contact throughout this process and will keep customers informed of replacement timing and any additional actions needed.
• Quantity in Commerce: 3 units
• Distribution: US Nationwide distribution in the states of OH, TX, SC VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.