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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Integra LifeSciences Corp.
Reason for Recall:
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0994-2014

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