Class 3 Device Recall Orthos CM Bracket, Orthodontic Metal Bracket,

• Date Initiated by Firm: February 13, 2009
• Date Posted: March 01, 2012
• Recall Status: Terminated on March 02, 2012
• Recall Number: Z-1136-2012
• Recall Event ID: 61221
• Product Classification: Bracket, metal, orthodontic - Product Code EJF
• Product: 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.
• Code Information: Part Number: Lot Number: 454-1210 08H599H 454-0210 08H358H, 08J174J, and 08J175J
• Recalling Firm/ Manufacturer: Ormco Corporation; 1332 S Lone Hill Ave; Glendora CA 91740
• For Additional Information Contact: 909-962-5600
• Manufacturer Reason for Recall: The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the brackets contained inside the packaging are actually Orthos CM Brackets with a torque of -9.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 304 units
• Distribution: Worldwide Distribution - USA (nationwide) and worldwide to Canada, Colombia, Hong Kong, Kuwait, United Arab Emirates, Mexico, Russia, South Africa, Croatia, Japan, France, Bulgaria, Germany, Estonia, United Kingdom, Hungary, Ireland, Italy, Netherlands, Australia, and New Zealand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.