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Class 2 Device Recall Cavity SpineWand |
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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
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Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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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
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For Additional Information Contact |
Field Action Department 901-566-7975
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = ARTHROCARE CORP.
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