Z-2836-2016Class II

Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin...

Name: Z-2836-2016 Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin...
Creator: Ormco/Sybronendo
Published: 2016-08-31
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2016-08-31 / Terminated / root cause: manufacturing process

FDA source

Ormco/Sybronendo began a recall of 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... on 2016-08-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2836-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-31
Posted: 2016-09-16
Terminated: 2017-09-01
Recalling firm: Ormco/Sybronendo
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.
Product code: KIF Resin, Root Canal Filling
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Kerr, sent an "Urgent: Medical Device Recall" letter dated 8/31/16 to its customers. The letter describes the product, problem and actions to be taken. The customer were instructed to contact SybronEndo Customer Care at (800) 537-7123 to receive a RMA number if they have any of the affected product; and to complete and email back the enclosed acknowledgement form to [email protected] , even if they do not have any of the affected product. If you have any questions, call 714-516-7802 or email to: [email protected].
Quantity in commerce: 179 units
Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden.
Product codes and lots: lot # 5-1310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2836-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2836-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-16

Product code KIF

K010940Class IISealapex 4Sybron Dental Specialties, Inc. / cleared 2001-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)