Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by SybronEndo, Glendora, CA. Intended a
FDA device recall Z-0917-2010 · posted 2010-03-02 · Terminated
Recall details
- Recalling firm
- Sybron Dental Specialties
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KIF
- Quantity affected
- 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, In
- Date initiated
- 2009-02-23
- Date posted
- 2010-03-02
- Date terminated
- 2012-03-21
- Location
- Orange, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM (K040940) | Olympus Corporation | 2004-04-19 |