Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Titanium Orthos Brackets Recalled by Ormco/Sybronendo Due to Ormco Corporation inititated recall of U2R Titanium Orthos...

Date: March 25, 2014
Company: Ormco/Sybronendo
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ormco/Sybronendo directly.

Affected Products

Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

Quantity: 150 units

Why Was This Recalled?

Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.

Where Was This Sold?

US and Canada.

About Ormco/Sybronendo

Ormco/Sybronendo has 16 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report