Recall Z-0917-2010 ยท KIF Resin, Root Canal Filling
Sybron Dental Specialties
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.
| Date | Mar 2, 2010 (initiated Feb 23, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040940 | BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM Olympus Corporation, Apr 19, 2004 |