FDA Medical Device Recalls (openFDA)
Sybronendo: Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
- Recall number
- Z-0488-2010
- Recalling firm
- Sybronendo
- Product
- Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002
- Status
- Terminated
- Initiated
- 2009-10-27
- Posted
- 2009-12-09
- Terminated
- 2012-03-22
- 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 distributor to identify and recover the affected product lots listed above that may have been shipped to their customers.
- 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
- Lot, serial or model codes
- Lot Numbers: 06 0959663, 06 0957595, 07 0987641, 08 0992277, 05 0941553, 05 0948690, 06 0955241, 07 0977947, 07 0987642, 08 0992278, 08 0998612
- 510(k) numbers
- ["K023819"]
- PMA numbers
- not on file
- Product code
- EKM
- Firm FEI
- 2024312
- Firm city
- Orange
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28