Class 2 Device Recall SCAcuFix Anterior Cervical Plating Systems

• Date Initiated by Firm: November 14, 2005
• Date Posted: December 17, 2005
• Recall Status: Terminated on October 02, 2007
• Recall Number: Z-0293-06
• Recall Event ID: 34015
• Product Classification: Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
• Product: SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems.
• Code Information: SC-AcuFix SlimLine Surgical Techniques: Doc #499-0005-MKC, rev D.
• Recalling Firm/ Manufacturer: 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: Other
• 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 2910 SC-AcuFix SlimLine 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.