Z-1521-06

OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966

Name: Z-1521-06 OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966
Creator: Kerr Corp
Published: 2006-08-29
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2006-08-29 / Terminated / root cause: labeling and UDI

FDA source

Kerr Corp began a recall of OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966 on 2006-08-29. The reason FDA records is "Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1521-06
Status: Terminated
Initiated: 2006-08-29
Posted: 2006-09-23
Terminated: 2012-08-03
Recalling firm: Sybron Dental Specialties, Inc.
Product: OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966
Product code: KLE Agent, Tooth Bonding, Resin
Reason for recall: Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A total of thirty-four (34) consignees were sent the recall communication via USPS 1st class mail on August 29, 2006. There will be an additional five (5) letters that will be sent to consignees in Europe once the recall communication is translated into their respective languages. 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. Periodic effectiveness checks will be conducted in order to follow up with non-responders.
Quantity in commerce: 247 Kits (50 unidose pouches/Kit)
Distribution: World wide; USA and countries of Australia, Belgium, Canada, China, France, Sweden and United Kingdom
Product codes and lots: Lot numbers: 448798, 449556 and 451706

Product code KLE

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)