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U.S. Department of Health and Human Services

Class 2 Device Recall XiVE Endosseous dental Implant

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  Class 2 Device Recall XiVE Endosseous dental Implant see related information
Date Initiated by Firm November 17, 2006
Date Posted December 01, 2006
Recall Status1 Terminated 3 on April 30, 2007
Recall Number Z-0231-2007
Recall Event ID 36844
510(K)Number K032750  
Product Classification Dental Implant - Product Code DZE
Product XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant)
Code Information Model # 26-0123
Recalling Firm/
Manufacturer		 Dentsply Friadent Ceramed
12860 W Cedar Dr Ste 101
Lakewood CO 80228-1965
For Additional Information Contact Kevin Walls
720-963-4730
Manufacturer Reason
for Recall		 Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product.
Quantity in Commerce 1685 units
Distribution Worldwide-USA and one Canadian consignee.
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 = FRIANDENT GMBH
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