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U.S. Department of Health and Human Services

Class 2 Device Recall Cavity SpineWand

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  Class 2 Device Recall Cavity SpineWand see related information
Date Initiated by Firm October 26, 2015
Date Posted January 08, 2016
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = ARTHROCARE CORP.
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