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U.S. Department of Health and Human Services

Class 3 Device Recall Heraeus Kulzer GLUMA Comfort Bond Desensitizer

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  Class 3 Device Recall Heraeus Kulzer GLUMA Comfort Bond Desensitizer see related information
Date Initiated by Firm July 09, 2007
Date Posted October 02, 2007
Recall Status1 Terminated 3 on March 12, 2008
Recall Number Z-0035-2008
Recall Event ID 44827
510(K)Number K992292  
Product Classification dental bonding agent - Product Code KLE
Product Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Code Information Lot 010065; exp. 02/2009.
Recalling Firm/
Manufacturer		 Heraeus Kulzer Inc., Dental Products Division
4315 S Lafayette Blvd
South Bend IN 46614-2517
For Additional Information Contact
800-431-1785
Manufacturer Reason
for Recall		 The material may solidify in the bottle, and thus be rendered unusable.
FDA Determined
Cause 2		 Process design
Action Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.
Quantity in Commerce 1,236
Distribution Nationwide and Canada.
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 = KLE and Original Applicant = HERAEUS KULZER, INC.
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