Recall Z-0488-2010 ยท EKM Gutta-Percha
Sybronendo
Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
| Date | Dec 9, 2009 (initiated Oct 27, 2009) |
| Status | Terminated |
| Reason | The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More Specifically, there exists a possibility that if the lock nut were to fail, the cart |
| Root cause | Component design/selection |
| Action | The recall communications was initiated on November 06, 2009 with the firm forwarding a Recall Letter to the affected consignees via US Postal Service 1st class mail. The recall letter informed the consignees of the reason for recall, the hazard and the affected products. Consignees were instructed to call SybronEndo Customer Care at 1-800-346-3636 directly to handle returns & replacements. In addition, consignees were asked to complete the enclosed Recall Return Form and return it by fax to 909-962-5605. The recall notice also instructed consignees that are an authorized SybronEndo distribut |
| Quantity | 5046 units (3720 units in US) |
| Distribution | Nationwide and Worldwide to: USA, Canada, Chile, China, Ecuador, Guatemala, Hong Kong, Japan, Malaysia, Singapore, Taiwan and Venezuela |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023819 | FIBERFILL SGP Pentron Clinical Technologies, Mar 26, 2003 |