Cook Inc. recalls Zenith Alpha Abdominal Endovascular Graft - Distributed OUS

Hazard / Issue

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

Issued by

FDA

Distribution: 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

Lot/Code Info: 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.