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.
Reported: September 28, 2016 Initiated: August 31, 2016 #Z-2836-2016
Product 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.
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.
Details
- Recalling Firm
- Ormco/Sybronendo
- Units Affected
- 179 units
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
- Location
- Glendora, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ormco/Sybronendo. Units affected: 179 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 28, 2016. Severity: Moderate. Recall number: Z-2836-2016.
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