Class 2 Device Recall

• Date Initiated by Firm: November 03, 2005
• Date Posted: November 26, 2005
• Recall Status: Terminated on January 11, 2006
• Recall Number: Z-0204-06
• Recall Event ID: 34016
• 510(K)Number: K052477
• Product Classification: Bracket, Plastic, Orthodontic - Product Code DYW
• Product: Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012
• Code Information: Lot Number 100514071 and 100512012
• Recalling Firm/ Manufacturer: Ormco Corporation; 1332 S Lone Hill Ave; Glendora CA 91740-5339
• For Additional Information Contact: Wendy Urtel; 949-255-8767
• Manufacturer Reason for Recall: Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
• FDA Determined Cause: Other
• Action: Telephone notification will be followed by letters sent via U.S. first class mail with mailing to commence on Thursday, 11/3/05.
• Quantity in Commerce: 1420
• Distribution: Nationwide
• 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