Events

Recall of Device Recall TOPAZ MicroDebrider

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ArthroCare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73525
  • Event Risk Class
    Class 2
  • Event Number
    Z-1321-2016
  • Event Initiated Date
    2016-03-03
  • Event Date Posted
    2016-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144400
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    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.
  • 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.

Device

Device Recall TOPAZ MicroDebrider
  • Model / Serial
    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
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • 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
  • Manufacturer
    ArthroCare Corporation

Manufacturer

ArthroCare Corporation
  • Manufacturer Address
    ArthroCare Corporation, 7000 W William Cannon Dr Bldg 1, Austin TX 78735-8509
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA