Z-0689-06

Tooth bonding resin. Nexus 2 Kit, Part Number 31954, Lot Number 428572

Name: Z-0689-06 Tooth bonding resin. Nexus 2 Kit, Part Number 31954, Lot Number 428572
Creator: Kerr Corp
Published: 2006-03-03
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2006-03-03 / Terminated

FDA source

Kerr Corp began a recall of Tooth bonding resin. Nexus 2 Kit, Part Number 31954, Lot Number 428572 on 2006-03-03. The reason FDA records is "The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0689-06
Status: Terminated
Initiated: 2006-03-03
Posted: 2006-03-28
Terminated: 2012-03-07
Recalling firm: Sybron Dental Specialties, Inc.
Product: Tooth bonding resin. Nexus 2 Kit, Part Number 31954, Lot Number 428572
Product code: KLE Agent, Tooth Bonding, Resin
Reason for recall: The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance.
FDA root cause: Other
Action: A total of one hundred thirty five (135) consignees were sent the recall communication via USPS 1st class mail and international fax/mail on March 3 and 6, 2006, respectively. There will be an additional thirty seven (37) letters to be sent to consignees in Australia and three (3) letters to be sent to consignees in New Zealand once the Australian Therapeutic Goods Administration approves of a differently formatted letter. The consignees were instructed to complete the Return Form and return any affected product in their inventory. They were also requested to recover any affected product that they may have shipped to their customers.
Quantity in commerce: 72
Distribution: Nationwide, Australia, Belgium, Canada, Denmark, Germany, Hungary, Italy, Russia, Spain, United Kingdom, & New Zealand.
Product codes and lots: Lot Number: 428572

Product code KLE

K991808Class IIOptibond Solo Plus 2Sybron Dental Specialties, Inc. / cleared 1999-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)