FDA-Device2016-09-28Class II
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.
Ormco/Sybronendo
Hazard
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.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
Affected count
179 units
Manufactured in
1332 S Lone Hill Ave, Glendora, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2836-2016Don't want to check this manually?
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