Z-1524-06

TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637

Name: Z-1524-06 TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
Creator: Kerr Corp
Published: 2006-08-14
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2006-08-14 / Terminated / root cause: manufacturing process

FDA source

Kerr Corp began a recall of TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637 on 2006-08-14. The reason FDA records is "Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)". 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-1524-06
Status: Terminated
Initiated: 2006-08-14
Posted: 2006-09-23
Terminated: 2012-08-03
Recalling firm: Sybron Dental Specialties, Inc.
Product: TempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637
Product code: EMA Cement, Dental
Reason for recall: Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured)
Root cause tag: manufacturing process
FDA root cause: Other
Action: A total of forty-one (41) consignees were sent the recall communication via USPS 1st class mail on August 14, 2006 and thirteen (13) consignees were sent the recall communication via international fax/mail on August 16. Additionally, there will be nine (9) letters sent to consignees in Australia and two (2) letters sent to consignees in New Zealand
Quantity in commerce: 2,007
Distribution: Class II Recall - Worldwide distribution ---- including USA and countries Canada, Denmark, France, Germany, Italy, Lithuania, Luxembourg, Mexico, Poland, South Africa, Spain and United Kingdom.
Product codes and lots: Lot numbers: 444881 and 445348.

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