Home / Recalls / ArthroCare Corporation / Z-1321-2016

Z-1321-2016 Class II Terminated

Recalled by ArthroCare Corporation — Austin, TX

FDA device recall Z-1321-2016 was initiated by ArthroCare Corporation on March 3, 2016 and is designated Class II. 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. The recall status is terminated (terminated May 17, 2017). Affected quantity: 26,903 devices.

Recall Details

Product Type
Devices
Report Date
April 13, 2016
Initiation Date
March 3, 2016
Termination Date
May 17, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
26,903 devices

Product Description

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

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.

Distribution Pattern

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.

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

Other recalls by ArthroCare Corporation

  • Z-2999-2020 Class II — Speed Stitch Needle Cassette (August 17, 2020)
  • Z-3000-2020 Class II — Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 012 (February 21, 2019)
  • Z-0623-2016 Class II — Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of (October 26, 2015)
  • Z-2105-2015 Class II — EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable (June 2, 2015)

FDA data resources