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Recall Observatory FDA recall evidence

Device 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.

Z-2836-2016

August 31, 2016

Class II

Product summary

Firm
Ormco/Sybronendo
Event
Event 75114
Status
Terminated
Classification
Class II
Quantity
179 units
Official record key
device-enforcement:Z-2836-2016

Official wording

Reason: 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.

Code information: lot # 5-1310

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.