Class 2 Device Recall Cavity SpineWand

• Date Initiated by Firm: October 26, 2015
• Date Posted: January 08, 2016
• Recall Status: Terminated on June 23, 2016
• Recall Number: Z-0623-2016
• Recall Event ID: 72789
• 510(K)Number: K063172
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
• Code Information: Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328
• FEI Number: 3010813691
• Recalling Firm/ Manufacturer: ArthroCare Corporation; 7000 W William Cannon Dr; Austin TX 78735-8509
• For Additional Information Contact: Field Action Department; 901-566-7975
• Manufacturer Reason for Recall: There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.
• FDA Determined Cause: Under Investigation by firm
• Action: Affected consignees will be notified via letter beginning 11/2/15.
• Quantity in Commerce: 262 units
• Distribution: Worldwide distribution. US nationwide including OH, MO, AZ, AL, CA, FL, SC, GA, and PA; Spain, France, United Kingdom, Germany, Switzerland, Singapore, Russia, Turkey, and Ecuador.
• 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 = GEI