Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Enforcement
- Recall Number
- Z-0994-2014
- Event ID
- 67406
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 26, 2014
- Initiation Date
- December 5, 2013
- Classification Date
- February 19, 2014
- Termination Date
- January 26, 2017
- Address
- 311 Enterprise Dr, Plainsboro, NJ, 08536-3344, United States
Description
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
All unexpired lot numbers for CEM Nosecone Gatalouge No. C6623 and C6636 from 1/1/2010 to present. CEM" Nosecone, Catalogue No. C6623: 1083655, 1084219, 1084398, 1084399, 1084400, 1084682, 1084683, 1090937, 1091712, 1091714, 1091715, 1093125, 1093126, 1093128, 1093129, 1093471, 1093847, 1094575, 1094740, 1095587, 1095873, 1100237, 1100238, 1101217, 1101547, 1101548, 1102069, 1102070, 1102544, 1102545, 1102546, 1103102, 1103392, 1103444, 1103445, 1103446, 1104264, 1104265, 1105065, 1105066, 1105067, 1110208, 1110311, 1110348, 1110349, 1110473, 1110474, 1110892, 1111760, 1112182, 1112808, 1112809, 1113175, 1113176, 1113177, 1113178, 1113662, 1114112, 1114654, 1114655, 1114656, 1115224, 1115225, 1115499, 1115500, 1115501, 1115853, 1115854, 1120771, 1120772, 1120773, 1120774, 1121141, 1121142, 1121383, 1121627, 1121628, 1122257, 1122259, 1122260, 1123050, 1123312, 1123915, 1124642, 1124643, 1124980, 1125393, 1125394, 1125933, 1130036, 1130037, 1130038, 1130039, 1130218, 1130219, 1130663, 1130664, 1131340, 1131344, 1131986, 1132207, 1132326, 1132327, 1132328, 1132880 CEM" Nosecone, Catalogue No. C6636: 1084216, 1084293, 1084377, 1084680, 1084681, 1090123, 1090124, 1090125, 1090126, 1090660, 1090661, 1090826, 1091395, 1091434, 1091700, 1092388, 1092389, 1092390, 1092391, 1092392, 1093012, 1093013, 1093130, 1093131, 1093472, 1093473, 1093474, 1093824, 1093825, 1093826, 1093827, 1094741, 1095104, 1095105, 1095106, 1095414, 1095415, 1095418, 1095419, 1100239, 1100240, 1100241, 1101220, 1101221, 1102647, 1102648, 1102649, 1102650, 1102651, 1103103, 1103394, 1103395, 1103437, 1103848, 1103851, 1103916, 1103917, 1103919, 1103920, 1103921, 1103922, 1104258, 1104259, 1104260, 1104261, 1104262, 1105068, 1105069, 1105070, 1110333, 1110975, 1110976, 1110977, 1111491, 1111492, 1111493, 1112186, 1112187, 1112211, 1112212, 1112769, 1112770, 1112771, 1113180, 1113181, 1113182, 1113183, 1113184, 1113664, 1113665, 1113666, 1114358, 1114359, 1114657, 1114658, 1114659, 1114660, 1115036, 1115037, 1115038, 1115039, 1115503, 1115504, 1115505, 1115855, 1115856, 1115857, 1115858, 1115859, 1115860, 1120360, 1120361, 1120362, 1120775, 1120776, 1120777, 1121568, 1121729, 1122344, 1122346, 1122347, 1123053, 1123054, 1123497, 1123498, 1123499, 1123500, 1123501, 1124054, 1124055, 1124703, 1124704, 1124705, 1124706, 1124707, 1124710, 1125395, 1125396, 1125397, 1125398, 1125399, 1125400, 1125476, 1125934, 1125935, 1125936, 1125937, 1125938, 1125939, 1130220, 1130221, 1130222, 1130223, 1130834, 1131243, 1131987, 1132777, 1132778, 1132779, 1132780, 1132879, 1133061, 1103850, 1103852, 1103917, 1103918, 1103922, 1104257, 1104263, 1105071, 1110475, 1110476, 1110978, 1111490, 1111493, 1112187, 1112188, 1112212, 1113179, 1113180, 1113663, 1114357, 1114358, 1114659, 1114660, 1115039, 1115502, 1115504, 1115505, 1120776, 1120777, 1121167, 1121168, 1121169, 1121565, 1121566, 1121567, 1122344, 1122743, 1123051, 1123052, 1123497, 1123498, 1123499, 1123500, 1123501, 1123508, 1123509, 1123510, 1123511, 1123512, 1124052, 1124053, 1124707, 1124709
Worldwide Distribution - USA Nationwide
17253 boxes