Class 3 Device Recall Spirit MB Brackets

• Date Initiated by Firm: May 18, 2011
• Date Posted: November 16, 2011
• Recall Status: Terminated on April 24, 2012
• Recall Number: Z-0201-2012
• Recall Event ID: 60118
• 510(K)Number: K943245
• Product Classification: Bracket, plastic, orthodontic - Product Code DYW
• Product: Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment.
• Code Information: Lot #111069607, 031144457
• Recalling Firm/ Manufacturer: Ormco Corporation; 1332 S Lone Hill Ave; Glendora CA 91740
• For Additional Information Contact: 909-962-5600
• Manufacturer Reason for Recall: Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
• FDA Determined Cause: Device Design
• Action: Ormco Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 13, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product. If any of the affected product is found, customers are directed to contact Ormco Customer Care at 1-800-854-1741 to receive a RMA number. The RMA number will allow a quick return and replacement or credit. Additionally, a Recall Return/ Acknowledgement Form was attached for customers to complete and return via fax to 909-962-5605.
• Quantity in Commerce: 135 packs
• Distribution: Worldwide Distribution-USA (nationwide) including the states of FL, MN, TX, and VA, and the countries of Australia, France, Germany, Italy, Japan, Mexico, Morocco, Netherlands, New Zealand, South Africa, Turkey, and Ukraine.
• 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.

• 510(K) Database: 510(K)s with Product Code = DYW