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U.S. Department of Health and Human Services

Class 2 Device Recall Sealapex Express

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  Class 2 Device Recall Sealapex Express see related information
Date Initiated by Firm February 23, 2009
Date Posted March 02, 2010
Recall Status1 Terminated 3 on March 21, 2012
Recall Number Z-0917-2010
Recall Event ID 53480
510(K)Number K040940  
Product Classification Resin, root canal filling - Product Code KIF
Product Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA.

Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.
Code Information Lot Numbers: 6-1314, 7-1221 and 7-1258. 
Recalling Firm/
Manufacturer
Sybron Dental Specialties
1717 W Collins Ave
Orange CA 92867-5422
For Additional Information Contact
714-516-7480
Manufacturer Reason
for Recall
Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of the root canal which may lead to an inadequate seal.
FDA Determined
Cause 2
Process control
Action SybronEndo initiated an "Urgent Medical Device Recall" notification dated February 19 , 2009. Consignees were instructed to complete a "return form" and return any affected product in their inventory to the firm. Any product returned will be replaced at no charge. For further information, contact SybronEndo Customer Care at 1-800-346-3636.
Quantity in Commerce 1309 units
Distribution Worldwide Distribution -- United States, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany, Spain, France, UK, Greece, Italy, Kuwait, Lebanon, Portugal, Russia, Sweden, Hong Kong, India, Malaysia and Taiwan.
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 = KIF and Original Applicant = OLYMPUS CORPORATION
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