Class II — Potential Health Hazard

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

Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Recalled by Ormco/Sybronendo Due to Ormco Corporation is voluntarily recalling one (1) lot...

Date: March 8, 2013
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

Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment

Quantity: 8210

Why Was This Recalled?

Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0¿) offset brackets, but actually contains distal (10¿) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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