Ormco/Sybronendo: Medical Device Recall in 2016 - (Recall #: Z-2836-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 31, 2016

Date Posted: September 28, 2016

Recall Number: Z-2836-2016

Event ID: 75114

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.

Status: Terminated

Product Quantity: 179 units

Code Information:

lot # 5-1310

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated