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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2964-2020

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): ZIMB-22-108 ZIMB-22-118 ZIMB-22-128 ZIMB-22-70 ZIMB-22-84 ZIMB-22-98 ZIMB-24-108 ZIMB-24-118 ZIMB-24-128 ZIMB-24-70 ZIMB-24-84 ZIMB-24-98 ZIMB-26-108 ZIMB-26-118 ZIMB-26-128 ZIMB-26-70 ZIMB-26-84 ZIMB-26-98 ZIMB-28-108 ZIMB-28-118 ZIMB-28-128 ZIMB-28-70 ZIMB-28-84 ZIMB-28-98 ZIMB-30-108 ZIMB-30-118 ZIMB-30-128 ZIMB-30-70 ZIMB-30-84 ZIMB-30-98 ZIMB-32-108 ZIMB-32-108 ZIMB-32-118 ZIMB-32-128 ZIMB-32-70 ZIMB-32-84 ZIMB-32-98 ZIMB-36-108 ZIMB-36-118 ZIMB-36-128 ZIMB-36-84 ZIMB-36-98

Publicado el 23 de septiembre de 2020 · Inicio del retiro: 11 de agosto de 2020

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU

Qué hacer

Voluntary: Firm initiated · E-Mail

Detalles del retiro

Fabricante
Cook Inc.
Distribuidor
Foreign Only: Canada SWEDEN AUSTRIA Belgium CZECH REPUBLIC DENMARK ESPA¿A FINLAND France GERMANY GREECE HUNGARY IRELAND ISRAEL Italia Nederland NORWAY POLAND PORTUGAL REUNION SERBIA SLOVENIA SOUTH AFRICA SWEDEN UNITED ARAB EMIRATES UNITED KINGDOM AUSTRALIA Hong Kong JAPAN NEW CALEDONIA New Zealand Thailand
Lote
Reference Part / Lot Numbers : ZIMB-22-108 9182141, 9983461, 10010790, 10136649, 13023971; ZIMB-22-118 10077065; ZIMB-22-70 9170948, 9196501, 9196502, 9311502, 9415647, 10156546, 10275239, 10337923; ZIMB-22-84 9100087, 9100089, 9118160, 9124830, 9132423, 9182145, 9403140, 9415636, 9415637, 9964029,9964055, 9974798, 9974799, 10153964,10153965, 10337925; ZIMB-22-98 9108371, 9163902, 9406786, 10136631, 10275243; ZIMB-24-108 9338301, 9854089, 9936720, 9936722, 9939734, 9939736, 9945749, 9945751, 9945753, 10318498; ZIMB-24-118 9100111, 9163853, 9959252, 9995361, 9999386, 10275245; ZIMB-24-128 9136557; ZIMB-24-70 9084499, 9118179, 9118180, 9163859, 9184781, 9196487, 9196590, 9300915, 9311508, 9338304,9978260, 9978261, 9983464, 10291632,13023978; ZIMB-24-84 9084507, 9118182, 9118183, 9118406, 9118409, 9163906, 9181250, 9196491, 9196593, 9279116, 9292346, 9321079, 9321083, 9324519, 9324521,9330492, 9330493, 9338306, 9365311, 9409601, 9409602, 9409604, 9959219, 9964025, 9964027,9964028, 9983471, 10017280, 10044210,10141902, 10141911, 10175395, 10175409, 10291637, 10291638, 10305523, 10305524,10332829, 10340274, 10340279, 13008932,13011201, 13020521, 13035543, 13041249,10056663XX, NS9088555; ZIMB-24-98 9076897, 9080500, 9080501, 9084510, 9084512, 9100134, 9100135, 9102515, 9118415, 9173828, 9321095, 9365312, 9373635, 9415651, 9964064,9969873, 9974816, 10052850, 10077067, 10098962, 10151099, 10186652, 13041251; ZIMB-26-108 9100142, 9163915, 9373477, 9904753, 9915021, 9930826, 9936725, 9936733, 9936734, 9953748, 10010796, 10010836, 10025525, 10108021,10175397, 10299712, 10309872, 13023989, 13023990; ZIMB-26-118 9286115, 10105275, 10299413, 13011587,13023992; ZIMB-26-70 9100151, 9217933, 9373479, 9373646, 9419035, 9425597, 9425598, 9915028, 9915029, 9915030,9995377, 9999389, 10025531, 10077068,13011591, 13015424, 13021170, 13023993, 13027639; ZIMB-26-84 9076909, 9076928, 9088530, 9118164, 9124843, 9196498, 9303243, 9303253, 9314216, 9321168, 9415652, 9415653, 9936744, 9978265, 10010848,10025534, 10130408, 10130411, 10139153, 10153985, 10225101, 10227951, 10282883,10331451, 13008934, 13008935, 13011595,13023997, 13030103, 13035545, 13035546,13035549, 13090261, 10139146X; ZIMB-26-98 9076932, 9088524, 9100103, 9108359, 9124922, 9170952, 9170972, 9181256, 9209904, 9307498,9307687, 9307688, 9321171, 9321173, 9376513,9376514, 9376516, 9425605, 9425607, 9978273, 9999333, 10017283, 10056684, 10105282,10113546, 10144804, 10153990, 10153991,10153992, 10227946, 10231315, 10309875,10331463, 10331489, 10331490, 13011600,13015425, 13027049, 13090267; ZIMB-28-108 9040730, 9869684, 9920813, 9920814, 9920817, 9951131, 9969884, 9969885, 9983493, 9999335,10022608, 10044216, 10056686, 10108037,10307420, 10332830, 13010195, 13011603, 13044015, 13188317; ZIMB-28-118 9064897, 9303288, 9412815, 9415641, 9425608, 9923193, 9969889, 10010800, 10031214,10047286, 13011606, 13041262 ZIMB-28-128 9193964, 9383486, 9915023, 9971444, 9974773, 10119913, 10119918, 10305544, 13027650; ZIMB-28-70 9037693, 9056000, 9064899, 9064901, 9088565, 9167748, 9212286, 9217990, 9226370, 9307689,9330495, 9330496, 9331479, 9338361, 9338362,9415633, 9415638, 9415643, 9425610, 9425613, 9930818, 9964070, 9966894, 10037025,10139135, 10139159, 10283657; ZIMB-28-84 9046402, 9136667, 9167751, 9190117, 9193974, 9212287, 9217995, 9226355, 9279120, 9303293,9303294, 9311539, 9314218, 9324565, 9324566,9324569, 9376519, 9383491, 9383496, 9415665, 9423252, 9425615, 9425636, 9425640, 9909088,9911870, 9948685, 9948691, 9966896, 9966900,9969905, 9986400, 9999343, 10022614,10022616, 10044217, 10044219, 10047287,10051143, 10052841, 10052868, 10068425, 10105284, 10154429, 10175398, 10175399,10271375, 10288149, 10297330, 10325658,10337931, 13010196, 13011613
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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