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U.S. Department of Health and Human Services

Class 2 Device Recall PathFinder Bone DrillAwlTap

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  Class 2 Device Recall PathFinder Bone DrillAwlTap see related information
Date Initiated by Firm July 18, 2007
Date Posted October 02, 2007
Recall Status1 Terminated 3 on April 02, 2008
Recall Number Z-0005-2008
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 stabilization system, Part Number 1156-60.
Code Information Part number 1156-60, lot number 44QS.
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 2		 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 and Original Applicant = SPINAL CONCEPTS, INC.
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