Class 2 Device Recall SybronEndo Elements Obturation Unit;

• Date Initiated by Firm: January 17, 2013
• Date Posted: June 14, 2013
• Recall Status: Terminated on November 07, 2013
• Recall Number: Z-1544-2013
• Recall Event ID: 64216
• 510(K)Number: K031664
• Product Classification: Plugger, root canal, endodontic - Product Code EKR
• Product: SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy; ; The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment.
• Code Information: Lot/Serial Numbers: 91-17011 to 91-19095; 91-20889 to 91-22339
• Recalling Firm/ Manufacturer: Ormco/Sybronendo; 1332 S Lone Hill Ave; Glendora CA 91740-5339
• For Additional Information Contact: Wendy Garman; 714-516-7602
• Manufacturer Reason for Recall: A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.
• FDA Determined Cause: Labeling mix-ups
• Action: The firm SybronEndo sent a "FIELD CORRECTION ACTION" letter dated January 30, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were requested to review and determine if they have any of the affected equipment in their inventory; Note: the equipment itself has not been modified in any way, and therefore there is no change in the performance; customers should continue to use the equipment in the same manner they have in the past:; Note: SynbronEndo has enclosed the cautionary label along with instructions for proper placement of the affected equipment; the customers should apply the enclosed cautionary statement label to Elements Obturation Unit and/or Replacement AC Power Cord as per instructions and complete and return the FIELD CORRECTION ACKNOWLEDGEMENT FORM ,whether or not they have any affected equipment in their inventory, via Fax to: 909-962-5605. For questions regarding this recall call 714-516-7602. Note: If you are an authorized SybronEndo international distributor, we request that you identify those customers that may have been shipped the affected lots of equipment and contact these customers to inform them of the issue within forty-eight (48) hours of receipt of this notification. If you have any questions, contact SybronEndo Customer Care at 1-800-346-3636.
• Quantity in Commerce: 3615 units total
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Italy, Japan, Kuwait, Latvia, Lebanon, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Romania, Russia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, and United Kingdom.
• 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 = EKR and Original Applicant = SYBRON ENDO/ANALYTIC