| Class 2 Device Recall Sealapex Xpress |  |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KIF
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