Z-1142-2012

Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1...

Name: Z-1142-2012 Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1...
Creator: Kerr Corporation
Published: 2010-05-27
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2010-05-27 / Terminated / root cause: manufacturing process

FDA source

Kerr Corporation began a recall of Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1 Prim/Adhesive Kit N01IAA Bond-1 Primer/Adhesive 4ml N01IAB... on 2010-05-27. The reason FDA records is "The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have 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-1142-2012
Status: Terminated
Initiated: 2010-05-27
Posted: 2012-03-02
Terminated: 2012-03-02
Recalling firm: Sybron Dental Specialties, Inc.
Product: Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description N01I Bond-1 Prim/Adhesive Kit N01IAA Bond-1 Primer/Adhesive 4ml N01IAB Bond-1 Primer/Adhesive 6ml N04 Lute-it w/ Bond-1 kit N04B Lute-t w/Bond-1 Intro Kit N31B Bond-1 C&B Prim/Adhesive N33 Cement-it Universal C&B Resin. 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: The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Pentron Clinical sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 7, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to complete and return an enclosed Recall Return Form via fax at 1-877-677-8844. Contact Pentron Clinical Customer Service at (800) 551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.
Quantity in commerce: 30,276 units total
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Germany, Canada, Ecuador, Egypt, Hong Kong, India, Israel, Japan, Kenya, Lebanon, Morocco, Saudi Arabia, Singapore, El Salvador, Thailand, Turkey, Taiwan, UAE, Vietnam, Armenia, Austria, Belgium, Bulgaria, Byelorussia, Cyprus, Germany, Spain, Russia, Finland, England, Greece, Hungary, Ireland, Italy, Latvia, Netherlands, Poland, Romania, Sweden, and Serbia.
Product codes and lots: Item # Bottle Lot # Package Lot# N01I 185597, 192338, 202233 186658, 194491, 202885 N01IAA 185597, 192372 184876, 185342, 192372 N01IAB 183352, 183845, 202233 183466, 183948, 203221 N04 191010 200816 N04B 185597 183127 N31B 184256, 197303 184464, 204774 N33 184256 180766

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)