Class 3 Device Recall Herculite Ultra

• Date Initiated by Firm: February 23, 2009
• Date Posted: March 02, 2010
• Recall Status: Terminated on March 19, 2012
• Recall Number: Z-0916-2010
• Recall Event ID: 53431
• 510(K)Number: K082671
• Product Classification: Material, tooth shade, resin - Product Code EBF
• Product: Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured by Kerr Corporation, Orange, CA.
• Code Information: Lot Number: 3161098.
• Recalling Firm/ Manufacturer: Sybron Dental Specialties; 1717 W Collins Ave; Orange CA 92867-5422
• For Additional Information Contact: 714-516-7480
• Manufacturer 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.
• FDA Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EBF