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U.S. Department of Health and Human Services

Class 2 Device Recall SCAcuFix Anterior Cervical Plating Systems

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  Class 2 Device Recall SCAcuFix Anterior Cervical Plating Systems see related information
Date Initiated by Firm November 14, 2005
Date Posted December 17, 2005
Recall Status1 Terminated 3 on October 02, 2007
Recall Number Z-0292-06
Recall Event ID 34015
510(K)Number K990005  K013979  K024326  
Product Classification Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Product SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems.
Code Information SC-AcuFix Core Instruments Surgical Techniques: Doc #499-0062-MKC, rev A.
Recalling Firm/
Abbott Spine
12708 Riata Vista Cir # B-100
Austin TX 78727-7167
Manufacturer Reason
for Recall
Modification to labeling for surgical implant.
FDA Determined
Cause 2
Action Firm contact of Sales Agencies by phone began on 11/11/05 to inform of changes to Surgical Techniques. Letter to surgeons using SC-AcuFix Systems as of 06/01/05 sent 11/14/05.
Quantity in Commerce Approximately 941 SC-AcuFix Core Instruments Surgical Techniques
Distribution Nationwide. Surgical Techniques for the SC-AcuFix Anterior Cervical Plating Systems distributed to Sales Agencies and surgeons throughout the U.S.
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.