The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -D

FDA device recall Z-0120-2013 · posted 2012-10-23 · Terminated

Recall details

Recalling firm

Ormco/Sybronendo

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.

Action taken

Ormco/Sybronendo sent an Urgent Medical Device Recall letter via USPS 1~1 class mail, on April 24, 2012 to all consignees. Consignees were sent an updated customer notification via USPS lSI class mail on June 28, 2012. The letters identified the affected product, problem and actions to be taken. Consignees were instructed to complete the Acknowledgement/Return Form and to return any affected product in their inventory. Customers were instructed to contact Ormco Customer Care at 1-800-854-1741 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.

Root cause

Labeling mix-ups

Status

Terminated

Product code

EJF

Quantity affected

148

Distribution

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.

Date initiated

2012-04-24

Date posted

2012-10-23

Date terminated

2012-12-12

Location

Glendora, CA