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.
Recall
- Recall Number
- Z-2836-2016
- Event Number
- 75114
- Firm
- Ormco/Sybronendo
- FEI Number
- 2016150
- Product Code
- KIF
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- August 31, 2016
- Posted
- September 16, 2016
- Terminated
- September 1, 2017
- Address
- 1332 S Lone Hill Ave, Glendora, CA, 91740-5339
Description
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.
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.
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 [email protected] , even if they do not have any of the affected product. If you have any questions, call 714-516-7802 or email to: [email protected].
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
179 units