Class 2 Device Recall Elements Gutta Percha and Elements RealSeal Cartridges

• Date Initiated by Firm: October 27, 2009
• Date Posted: December 09, 2009
• Recall Status: Terminated on March 22, 2012
• Recall Number: Z-0488-2010
• Recall Event ID: 53812
• 510(K)Number: K023819
• Product Classification: Gutta Percha - Product Code EKM
• Product: Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
• Code Information: Lot Numbers: 06 0959663, 06 0957595, 07 0987641, 08 0992277, 05 0941553, 05 0948690, 06 0955241, 07 0977947, 07 0987642, 08 0992278, 08 0998612
• Recalling Firm/ Manufacturer: Sybronendo; 1717 W Collins Ave; Orange CA 92867
• Manufacturer Reason for Recall: The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility that if the lock nut were to fail, the cart
• FDA Determined Cause: Component design/selection
• Action: The recall communications was initiated on November 06, 2009 with the firm forwarding a Recall Letter to the affected consignees via US Postal Service 1st class mail. The recall letter informed the consignees of the reason for recall, the hazard and the affected products. Consignees were instructed to call SybronEndo Customer Care at 1-800-346-3636 directly to handle returns & replacements. In addition, consignees were asked to complete the enclosed Recall Return Form and return it by fax to 909-962-5605. The recall notice also instructed consignees that are an authorized SybronEndo distributor to identify and recover the affected product lots listed above that may have been shipped to their customers.
• Quantity in Commerce: 5046 units (3720 units in US)
• Distribution: Nationwide and Worldwide to: USA, Canada, Chile, China, Ecuador, Guatemala, Hong Kong, Japan, Malaysia, Singapore, Taiwan and Venezuela
• 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 = EKM