Ormco/Sybronendo: Medical Device Recall in 2012 - (Recall #: Z-0120-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

Product Classification:

Class III

Date Initiated: April 24, 2012

Date Posted: October 31, 2012

Recall Number: Z-0120-2013

Event ID: 63296

Reason for Recall:

The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets.

Status: Terminated

Product Quantity: 148

Code Information:

Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039

Distribution Pattern:

Worldwide Distribution - US Nationwide and the countries of Canada, China, Costa Rica, Ecuador, French Polynesia, India, Kuwait, Malaysia, Philippines, Singapore, South Korea, Thailand and UAE.

Voluntary or Mandated:

Voluntary: Firm initiated