Class 2 Device Recall TOPAZ MicroDebrider

• Date Initiated by Firm: March 03, 2016
• Date Posted: April 05, 2016
• Recall Status: Terminated on May 17, 2017
• Recall Number: Z-1321-2016
• Recall Event ID: 73525
• 510(K)Number: K080282
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
• Code Information: 1031506, 1031507, 1032123, 1032325, 1032741, 1032742, 1033443, 1033965, 1033966, 1034397, 1039120, 1041765, 1044089, 1044090, 1045862, 1048237, 1048933, 1049185, 1052071, 1056212, 1060586, 1060979, 1063394, 1064599, 1067696, 1067748, 1069174, 1071358, 1074125, 1075714, 1070521, 1070812, 1071974, 1078025, 1077499, 1082811, 1084095, 1084094, 1085458, 1086436, 1086437, 1087917, 1094313, 1097573, 1103824, 1107183, 1107297, 1113562, 1113563, 1114534, 1114535, 1114536, 1115896, 1031518, 1032308, 1032309, 1032310, 1032755, 1032756, 1033972, 1033973, 1034225, 1034226, 1035283, 1035284, 1038547, 1043507, 1046556, 1047064, 1048722, 1049266, 1051812, 1052070, 1054443, 1055730, 1059865, 1063661, 1067691, 1067273, 1067747, 1068019, 1069172, 1071357, 1072853, 1072854, 1070497, 1070808, 1071971, 1076849, 1077450, 1079140, 1079220, 1078115, 1081753, 1082361, 1082810, 1086380, 1094312, 1094312, 1094721, 1097571, 1101041, 1107295, 1109045, 1111935, 1111936, 1113534, 1113535, 1113536, 1114532, 1115888, 1115891, 1116959, 1116130, 1116720, 1117209, 1117214, 1031341, 1032311, 1033761, 1034446, 1035691, 1035692, 1041775, 1043962, 1046557, 1048236, 1050067, 1052651, 1057008, 1058808, 1059867, 1063665, 1064594, 1067695, 1068021, 1071319, 1071320, 1073441, 1074876, 1077498, 1080520, 1114533, 1115893, 1031340, 1032962, 1033266, 1045359, 1047065, 1051331, 1056849, 1064592, 1067694, 1070709
• Recalling Firm/ Manufacturer: ArthroCare Corporation; 7000 W William Cannon Dr Bldg 1; Austin TX 78735-8509
• For Additional Information Contact: Field Actions Department; 901-566-7975
• Manufacturer Reason for Recall: During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.
• FDA Determined Cause: Package design/selection
• Action: Consignees were notified via letter on 3/3/2016. Consignees were instructed to quarantine the recalled products and complete an Inventory Return Certification Form.
• Quantity in Commerce: 26,903 devices
• Distribution: Worldwide Distribution-US (nationwide) and the following countries-Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Ireland, Israel, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, China, Hong Kong, India, Lebanon, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arabic Emirates, Vietnam, Australia, Japan, New Zealand, Brazil, and Chile.
• 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.