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.
This recall has been terminated (originally issued September 16, 2016).
- Company
- Ormco/Sybronendo
- Recall Initiated
- August 31, 2016
- Posted
- September 16, 2016
- Terminated
- September 1, 2017
- Recall Number
- Z-2836-2016
- Quantity
- 179 units
- Firm Location
- Glendora, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
Lot / Code Info
lot # 5-1310
Root Cause
Employee error
Action Taken
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.