Z-0917-2010

Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA...

Name: Z-0917-2010 Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA...
Creator: Sybron Dental Specialties
Published: 2009-02-23
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2009-02-23 / Terminated / root cause: manufacturing process

FDA source

Sybron Dental Specialties began a recall of Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is... on 2009-02-23. The reason FDA records is "Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from...". 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-0917-2010
Status: Terminated
Initiated: 2009-02-23
Posted: 2010-03-02
Terminated: 2012-03-21
Recalling firm: Sybron Dental Specialties, Inc.
Product: Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended as a root canal filling material that is used in conjunction with gutta percha or silver endodontic points.
Product code: KIF Resin, Root Canal Filling
Reason for recall: Sybron Dental Specialties is initiating a recall on the Sealapex Xpress due to the presence of crystals in the catalyst. This crystallization may affect proper canal filling by preventing Gutta Percha Points from reaching the bottom of the root canal which may lead to an inadequate seal.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: SybronEndo initiated an "Urgent Medical Device Recall" notification dated February 19 , 2009. Consignees were instructed to complete a "return form" and return any affected product in their inventory to the firm. Any product returned will be replaced at no charge. For further information, contact SybronEndo Customer Care at 1-800-346-3636.
Quantity in commerce: 1309 units
Distribution: Worldwide Distribution -- United States, Australia, Canada, United Arab Emirates, Belgium, Bulgaria, Germany, Spain, France, UK, Greece, Italy, Kuwait, Lebanon, Portugal, Russia, Sweden, Hong Kong, India, Malaysia and Taiwan.
Product codes and lots: Lot Numbers: 6-1314, 7-1221 and 7-1258.

Product code KIF

K040940Class IIBronchovideoscope Olympus Xbf-D160hmOlympus Corporation / cleared 2004-04-19

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)