Z-1321-2016 Class II Terminated
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