Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002

FDA device recall Z-0488-2010 · posted 2009-12-09 · Terminated

Recall details

Recalling firm

Sybronendo

Reason for recall

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

Action taken

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 distributor to identify and recover the affected product lots listed above that may have been shipped to their customers.

Root cause

Component design/selection

Status

Terminated

Product code

EKM

Quantity affected

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

Date initiated

2009-10-27

Date posted

2009-12-09

Date terminated

2012-03-22

Location

Orange, CA

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