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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm November 01, 2003
Date Posted March 15, 2005
Recall Status1 Terminated 3 on April 05, 2005
Recall Number Z-0624-05
Recall Event ID 29993
510(K)Number K030318  
Product Classification Material, Impression - Product Code ELW
Product Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585.
Code Information Lots 190429, 190438, 190519, 190521, 190522, 190524, 190535, 190545, 190547, 190554 and 190560.
Recalling Firm/
Manufacturer		 Heraeus Kulzer Inc.
4315 S Lafayette Blvd
South Bend IN 46614-2517
For Additional Information Contact
800-431-1785
Manufacturer Reason
for Recall		 Packaging defects could result in improper mixing ratios and unusable impressions.
FDA Determined
Cause 2		 Other
Action Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand..
Quantity in Commerce 807 bags.
Distribution Nationwide.
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 = ELW and Original Applicant = HERAEUS KULZER, INC.
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