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U.S. Department of Health and Human Services

Class 2 Device Recall EP Healing abutment

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  Class 2 Device Recall EP Healing abutment see related information
Date Initiated by Firm October 16, 2006
Date Posted June 14, 2007
Recall Status1 Terminated 3 on December 30, 2008
Recall Number Z-0922-2007
Recall Event ID 36616
510(K)Number K934126  
Product Classification Healing abutment - Product Code DZE
Product EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
Code Information Lot Number: 560988
Recalling Firm/
Manufacturer		 Biomet 3i
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
Manufacturer Reason
for Recall		 Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
FDA Determined
Cause 2		 Other
Action Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.
Distribution Worldwide.
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 = DZE and Original Applicant = IMPLANT INNOVATIONS, INC.
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