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.

Reason: 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.

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.