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Ormco/Sybronendo recalls Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex
Recalled September 28, 2016 · FDA recall Z-2836-2016 · 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. · FDA Class II
Units
179 units
Sold at
Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
Description
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.
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.
Manufacturer(s)
Ormco/Sybronendo
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →