Z-0261-2009

PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite

Name: Z-0261-2009 PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite
Creator: Kerr Corp
Published: 2008-09-05
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2008-09-05 / Terminated / root cause: design

FDA source

Kerr Corp began a recall of PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite on 2008-09-05. The reason FDA records is "Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0261-2009
Status: Terminated
Initiated: 2008-09-05
Posted: 2008-11-25
Terminated: 2012-03-07
Recalling firm: Sybron Dental Specialties, Inc.
Product: PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time.
Root cause tag: design
FDA root cause: Component design/selection
Action: Kerr sent an Urgent Medical Device Recall letter to consignees via USPS first class mail the week of September 8, 2008, requesting they return the product for replacement or credit. The recall notification requested the return of the affected products because the material appears to stiffen and become difficult to extrude over time. Customers were instructed if they have any of the affected lots of product in their inventory to immediately return it to Kerr. Any product returned will be replaced at no charge or credited to your account. In addition, customers were instructed to fax the attached Recall Return Form to 714-516-7739. If the customers were an authorized Kerr distributor, they were requested to identify and recover the affected product lots listed on the attached Lot Number Table that may have been shipped to their customers. Also, customers were instructed to contact Kerr Customer Care at 1 -800-537-7123 directly to handle the arrangements of a quick return and replacement
Quantity in commerce: 22,478 packs for all affected lots
Distribution: Worldwide: USA, Australia, Canada, Hong Kong, Malaysia, Mexico, and Singapore.
Product codes and lots: LOT NUMBER(S): 3001323, and 3001324

Product code EBF

K060472Class IIPremise FlowableKerr Corporation / cleared 2006-04-28

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)