Events

Rappel de Device Recall Integra LifeSciences Corporation

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Integra LifeSciences Corp..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67406
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0994-2014
  • Date de mise en oeuvre de l'événement
    2013-12-05
  • Date de publication de l'événement
    2014-02-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125409
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    The blue coag button on the cusa excel cem nosecone could stick in the 'activated' position.
  • Action
    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.

Device

Device Recall Integra LifeSciences Corporation
  • Modèle / numéro de série
    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
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Description du dispositif
    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.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.