Home / Recalls / Ormco/Sybronendo / Z-2836-2016

Z-2836-2016 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
September 28, 2016
Initiation Date
August 31, 2016
Termination Date
September 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
179 units

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.

Distribution Pattern

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

Code Information

lot # 5-1310

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