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U.S. Department of Health and Human Services

Class 2 Device Recall SybronEndo Replacement AC Power Cord, US Elements Obturation;

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 Class 2 Recall
SybronEndo Replacement AC Power Cord, US Elements Obturation;
see related information
Date Posted June 14, 2013
Recall Status1 Terminated on November 07, 2013
Recall Number Z-1545-2013
Recall Event ID 64216
Premarket Notification
510(K) Number
K031664 
Product Classification Plugger, Root Canal, Endodontic - Product Code EKR
Product SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan 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: 3757349, 4220920, 4304917, 4367699, 436513, 4445719, 4458262, 4522605, 4581118, 4724407, 4730212
Recalling Firm/
Manufacturer
Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora, California 91740-5339
Consumer Instructions Contact the recalling firm for information
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 2
PRODUCTION CONTROLS: 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 unit 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = EKR and Original Applicant = SYBRON ENDO/ANALYTIC
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