Sybron Dental Specialties Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.
Brand
Sybron Dental Specialties
Lot Codes / Batch Numbers
Lot Number: 3161098.
Products Sold
Lot Number: 3161098.
Sybron Dental Specialties is recalling Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Cor due to Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the di. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026