Z-0916-2010

Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation...

Name: Z-0916-2010 Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation...
Creator: Sybron Dental Specialties
Published: 2009-02-23
License: https://open.fda.gov/license/

Sybron Dental Specialties, Inc. / initiated 2009-02-23 / Terminated / root cause: labeling and UDI

FDA source

Sybron Dental Specialties began a recall of Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA on 2009-02-23. The reason FDA records is "Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0916-2010
Status: Terminated
Initiated: 2009-02-23
Posted: 2010-03-02
Terminated: 2012-03-19
Recalling firm: Sybron Dental Specialties, Inc.
Product: Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.
Product code: EBF Material, Tooth Shade, Resin
Reason for recall: Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Kerr Corporation issued a letter dated February 23, 2009. Users were informed of the affected product and instructed on proper return. For further information, contact Kerr Customer Care at 1-800-537-7123.
Quantity in commerce: 442
Distribution: Nationwide distribution
Product codes and lots: Lot Number: 3161098.

Product code EBF

K082671Class IIHerculite UltraSybron Dental Specialties / cleared 2008-12-11

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)