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U.S. Department of Health and Human Services

Class 2 Device Recall AntCer

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  Class 2 Device Recall AntCer see related information
Date Initiated by Firm March 01, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 13, 2007
Recall Number Z-0807-04
Recall Event ID 28505
510(K)Number K024326  
Product Classification Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Product One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
Code Information All lots in the market.
Recalling Firm/
Manufacturer		 Spinal Concepts, Inc
5301 Riata Park Ct Bldg F
Austin TX 78727-3436
Manufacturer Reason
for Recall		 Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
FDA Determined
Cause 2		 Other
Action The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
Quantity in Commerce 15 (1706-1024); 14 (1706-1026); 17 (1706-1028); 8 (1706-1030); 8 (1706-1032); and 25 (1757-1)
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 = KWQ and Original Applicant = SPINAL CONCEPTS, INC.
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