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U.S. Department of Health and Human Services

Class 3 Device Recall Herculite Ultra

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  Class 3 Device Recall Herculite Ultra see related information
Date Initiated by Firm February 23, 2009
Date Posted March 02, 2010
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SYBRON DENTAL SPECIALTIES
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