Class 2 Device Recall PathFinder Bone DrillAwlTap

• Date Initiated by Firm: July 18, 2007
• Date Posted: October 02, 2007
• Recall Status: Terminated on April 02, 2008
• Recall Number: Z-0004-2008
• Recall Event ID: 38449
• 510(K)Number: K030625
• Product Classification: spinal stablization system component - Product Code NKB
• Product: PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
• Code Information: Part Numbers 1156-50, lot number 44QR.
• Recalling Firm/ Manufacturer: Abbott Spine; 12708 Riata Vista Cir # B-100; Austin TX 78727-7167
• For Additional Information Contact: 512-918-2700
• Manufacturer Reason for Recall: Tip of PathFinder surgical instrument broke during procedure.
• FDA Determined Cause: Device Design
• Action: Firm notified sales representatives with an approved phone script on 7/18/2007.
• Quantity in Commerce: 11 units
• 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 = NKB