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Class 2 Device Recall Zenith Alpha Abdominal Endovascular Graft |
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Date Initiated by Firm |
August 11, 2020 |
Create Date |
September 12, 2020 |
Recall Status1 |
Terminated 3 on July 28, 2021 |
Recall Number |
Z-2964-2020 |
Recall Event ID |
86242 |
Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
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Product |
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
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Code Information |
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. |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact |
Cook Medical Customer Relations Department 800-457-4500
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Manufacturer Reason for Recall |
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
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Cook Medical issued Urgent Medical Device Recall Dated 8/11/20 either mailed via courier or emailed to consignees
stating reason for recall, health risk and action to take: Examine inventory immediately to determine if you have affected product(s) and quarantine any
affected product that remains unused. Immediately cease all distribution and use of this product.
2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions.
Note: Unaffected products that are returned will not be credited.
3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email FieldActionsNA@CookMedical.com).
This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred.
5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. |
Quantity in Commerce |
684 units |
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 |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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