Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

Ormco Corporation sent an Urgent Field Safety Notice dated February 13, 2009, to all affected customers. The recall communication for consignees in the United States, Canada, Colombia, HongKong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa and Croatia was sent on February 13, 2009 via USPS First Class Mail. The recall communication for consignees in Japan was sent on February 17, 2009. European consignees were sent recall notification on February 23, 2009. The Australian consignees and New Zealand consignees were the sent recall communication on February 25, 2009. Customers were instructed to contact Ormco Customer Care at (800) 854-1741 to receive an RMA number. The affected product should be returned to Ormco Corporation at the following address: Ormco Corporation, 1332 South Lone Hill Avenue, Glendora, CA 91740. Customers were instructed to label their return product "RECALLED PRODUCT Attention: Customer Returns". Customers were instructed to complete the enclosed Return Form and return it by fax to (909) 962-5605. For questions regarding this recall call 909-962-5600.