Z-1150-2010

Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling...

Name: Z-1150-2010 Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling...
Creator: Sybron Dental Specialties
Published: 2009-08-24
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2009-08-24 / Terminated / root cause: manufacturing process

FDA source

Sybron Dental Specialties began a recall of Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners... on 2009-08-24. The reason FDA records is "Some of the material has been found to be gelled and therefore becomes unusable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1150-2010
Status: Terminated
Initiated: 2009-08-24
Posted: 2010-03-16
Terminated: 2012-02-24
Recalling firm: Sybron Dental Specialties, Inc.
Product: Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
Product code: KLE Agent, Tooth Bonding, Resin
Reason for recall: Some of the material has been found to be gelled and therefore becomes unusable.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An "Urgent Medical Device Recall" letter and "Recall Return Form" were sent by first class mail on August 24, 2009 to consignees. The letter acknowledged the "gelling" issue of identified lots shipped between July 2009 & August 2009. Customers were requested to return any of the remaining affected lots in their inventory. Contact Customer Service by calling 1-800-551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.
Quantity in commerce: 1,400
Distribution: Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
Product codes and lots: Lots 186620, 190582 and 190985.

Product code KLE

K973388Class IIDentin Conditioning and Adhesive (Bond 1)Jeneric/Pentron, Inc. / cleared 1997-09-12

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)