Z-0074-2010

Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a...

Name: Z-0074-2010 Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a...
Creator: Kerr Corp
Published: 2009-09-09
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2009-09-09 / Terminated / root cause: manufacturing process

FDA source

Kerr Corp began a recall of Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be... on 2009-09-09. The reason FDA records is "The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product 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-0074-2010
Status: Terminated
Initiated: 2009-09-09
Posted: 2009-10-23
Terminated: 2011-12-12
Recalling firm: Sybron Dental Specialties, Inc.
Product: Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended for use in a dual-cured, temporary resin-based cement designed to be used in conjunction with temporary restoration such as crowns, bridges, inlays and onlays.
Product code: EMA Cement, Dental
Reason for recall: The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Kerr Corporation issued an "Urgent Medical Device Recall" dated September 8, 2009. The letter informed customers that the product recalled was shipped to their establishment between June and July 2009 and if they have any of the affected products listed to contact Kerr Customer Care at 1-800-537-7123 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.
Quantity in commerce: 13,518 units
Distribution: Worldwide Distribution -- United States, Canada, Mexico, Hong Kong, Israel, Singapore, Colombia, Dominican Republic and Europe.
Product codes and lots: Part Number 33351, Lot Numbers: 3252902, 3229807, 3268505, 3277455, 3257280, 3258772 and 3269811.

Product code EMA

K982590Class IITempbond Clear-2Sybron Dental Specialties, Inc. / cleared 1998-10-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)