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U.S. Department of Health and Human Services

Class 2 Device Recall Sealapex Xpress

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  Class 2 Device Recall Sealapex Xpress see related information
Date Initiated by Firm August 31, 2016
Date Posted September 16, 2016
Recall Status1 Terminated 3 on September 01, 2017
Recall Number Z-2836-2016
Recall Event ID 75114
510(K)Number K010940  
Product Classification Resin, root canal filling - Product Code KIF
Product Sealapex Xpress, Part No. 33639

The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
Code Information lot # 5-1310
Recalling Firm/
Manufacturer
Ormco/Sybronendo
1332 S Lone Hill Ave
Glendora CA 91740-5339
For Additional Information Contact
909-962-5600
Manufacturer Reason
for Recall
SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.
FDA Determined
Cause 2
Employee error
Action The firm, Kerr, sent an "Urgent: Medical Device Recall" letter dated 8/31/16 to its customers. The letter describes the product, problem and actions to be taken. The customer were instructed to contact SybronEndo Customer Care at (800) 537-7123 to receive a RMA number if they have any of the affected product; and to complete and email back the enclosed acknowledgement form to Sealapex.Response@kerrdental.com , even if they do not have any of the affected product. If you have any questions, call 714-516-7802 or email to: mark.dzendzel@syndrondental.com.
Quantity in Commerce 179 units
Distribution Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
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 = SYBRON DENTAL SPECIALTIES, INC.
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