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
Enforcement
- Recall Number
- Z-2964-2020
- Event ID
- 86242
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cook Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- September 23, 2020
- Initiation Date
- August 11, 2020
- Classification Date
- September 11, 2020
- Termination Date
- July 28, 2021
- Address
- 750 N Daniels Way, N/A, Bloomington, IN, 47404-9120, United States
Description
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
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
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, 13021173,13027655, 13050699, 13101560, 10141924X; ZIMB-28-98 9037752, 9046415, 9055991, 9064922, 9124929, 9124932, 9136670, 9143825, 9218000, 9234946,9283231, 9373486, 9373488, 9376523, 9383415,9383501, 9425633, 9911865, 9911867, 9913326, 9913327, 9920819, 9920820, 9948687, 9948692,9956372, 9982267, 10007633, 10059719,10059720, 10136638, 10332808, 13008942, 13010340, 13021175, 13021177, 13078502,13101562; ZIMB-30-108 9212304, 9307494, 9307701, 9361542, 9904221, 9911853, 9911860, 9966907, 9969909, 9978296,9982268, 9999348, 10013746, 10129802,10156556, 10223556, 13078507, 13078509, 9904230X, NS9218007; ZIMB-30-118 9040636, 9056086, 9415666, 9959246, 9999350, 10001828, 10013748, 10132963, 10156542, 10156558, 10163202; ZIMB-30-128 9136542, 9283236, 9307703, 10047290,10156560, 13020527, 13199408; ZIMB-30-70 9423255, 9904219, 9992839, 10007637, 10007638, 10037030, 10156561, 10327926,13012746, 9933334X; ZIMB-30-84 9053445, 9056095, 9060405, 9150335, 9185031, 9185032, 9185034, 9190254, 9292350, 9292355, 9334354, 9338287, 9404792, 9426588, 9930856, 9971412, 9971451, 10044221, 10051128, 10059685, 10098974, 10156565, 10156567, 10315171, 10315172, 13030115, 13030117, 13050689, 13094868; ZIMB-30-98 9037765, 9060395, 9060412, 9060414, 9193801, 9206515, 9212249, 9242441, 9933350, 9974777, 9982278, 9986414, 10007647, 10017296, 10037041, 10062767, 10062768, 10062770, 10119927, 10119928, 10119929, 10136643, 10156538, 10271379, 10315173, 10331468, 10343161, 13030124, 13032866, 13078512, 13105397, 10052870X ZIMB-32-108 9034048, 9060448, 9159951, 9159952, 9167820, 9283243, 9383406, 9945758, 9982284, 9983455, 9986419, 10126202, 10156568, 10337935; ZIMB-32-118 9143871, 9391316, 9917748, 9948669, 9982251, 9995331, 10136646, 13011206, 13014574; ZIMB-32-128 9037772, 9159955, 9361554, 9423265, 10156570; ZIMB-32-84 9040645, 9136551, 9159958, 9159959, 9159962, 9167828, 9193807, 9193809, 9239290, 9239292, 9242443, 9301043, 9330500, 9373494, 9391318, 9406725, 9406728, 9917759, 9951141, 9982291, 9986422, 9995339, 10007656, 10007660, 10013759, 10017297, 10017298, 10051126, 10051157, 10062699, 10062781, 10073701, 10077029, 10110453, 10156572, 10288184, 10297335, 10299417, 10307043, 13098184, 13105403; ZIMB-32-98 9060391, 9060393, 9088571, 9132417, 9201608, 9214705, 9217930, 9234937, 9234938, 9234939, 9286012, 9286110, 9307514, 9324523, 9406730, 9406733, 9406735, 9423268, 9936717, 9936719, 9974787, 9986425, 9999375, 10007664, 10013762, 10062785, 10077088, 10113555, 10126227, 10163191, 10163203, 10167625, 10335581, 13010201, 13030131, 13030132, 13030133, 13082901, 13105407; ZIMB-36-108 9130033, 9150330, 9159890, 9365255, 9386647, 9406737, 9406738, 9995345, 9999376, 10139139, 13030135, 13074793, 13082903; ZIMB-36-118 9132489, 9376500, 10129806, 10151121; ZIMB-36-128 9915031, 10090273; ZIMB-36-84 9132418, 9132427, 9132428, 9132496, 9184767, 9303240, 9330504, 9330505, 9406742, 9904232, 9974792, 10077064, 10307049, 13035572; ZIMB-36-98 9132500, 9391321, 9959249, 10110457, 10166133, 10167626, 10297331, 10331476.
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
684 units