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

FDA device recall Z-2699-2026 · posted 2026-07-08 · Open, Classified

Recall details

Recalling firm

Klowen Braces

Reason for recall

A product error defect may cause incorrect bracket placement.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

QJJ

Quantity affected

3 units

Distribution

US Nationwide distribution in the states of OH, TX, SC VA.

Date initiated

2026-06-08

Date posted

2026-07-08

Location

Richardson, TX