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.
FDA Recall Z-0917-2010 · Posted 2010-03-02
Recalling FirmSybron Dental Specialties
Recall StatusTerminated
Product CodeKIF
Date Initiated2009-02-23
Date Terminated2012-03-21
Product Quantity1309 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.