—#125409

Product

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.

Affected lot / code info: 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

Why it was recalled

The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Integra sent an Urgent: Medical Device Correction Letter/Acknowledgement Return Form dated December 5, 2013 via traceable courier to their customers. The notification: advises customers of the nature of the issue and how it could affect CEM Nosecone use, advises customers what to do if the issue occurs and requests customers complete and return the Acknowledgment Return Form. The form should be faxed to rc@integralife.com or 1-609-275-9445. Any questions can be directed to customer service at 855-532-1723.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide

Timeline

Recall initiated: 2013-12-05
Posted by FDA: 2014-02-20
Terminated: 2017-01-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125409. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.