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U.S. Department of Health and Human Services

Class 2 Device Recall SCAcuFix Thinline

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  Class 2 Device Recall SCAcuFix Thinline see related information
Date Initiated by Firm July 01, 2002
Date Posted June 11, 2005
Recall Status1 Terminated 3 on December 20, 2005
Recall Number Z-0880-05
Recall Event ID 30399
510(K)Number K013979  
Product Classification Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Product SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas
Code Information All devices lot number 10RY and earlier of the following part numbers were removed from the market in 2002: 407-1020; 407-1022; 407-1024; 407-1026; 407-1028; 407-1030; 407-1032; 407-1034; 407-2236; 407-2238; 407-2240; 407-2242; 407-2244; 407-2246; 407-2248; 407-2250; 407-2252; 407-2254
Recalling Firm/
Manufacturer		 Spinal Concepts, Inc
5301 Riata Park Ct Bldg F
Austin TX 78727-3436
Manufacturer Reason
for Recall		 Complaints were recieved where swivels came out of plate and where the screw went through the plate.
FDA Determined
Cause 2		 Other
Action The firm initiated the recall via telephone communication from sales representatives around August 2002.
Quantity in Commerce 10 systems
Distribution Systems were distributed to hospitals in CA, IL, IN, NC, MS, PA, NY and VA
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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