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U.S. Department of Health and Human Services

Class 2 Device Recall K113551 Esophageal TTS Stent K123205 Esophageal TTS Stent K080782 NitiS Esophageal Stent

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 Class 2 Device Recall K113551 Esophageal TTS Stent K123205 Esophageal TTS Stent K080782 NitiS Esophageal Stentsee related information
Date Initiated by FirmOctober 18, 2019
Create DateFebruary 14, 2020
Recall Status1 Terminated 3 on October 15, 2021
Recall NumberZ-1229-2020
Recall Event ID 84742
510(K)NumberK080782 K113551 K123205 
Product Classification Prosthesis, esophageal - Product Code ESW
ProductNiti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F
Code Information Serial #: 16D5429C9IE565, 16K4777C9IE566, 16K4066C9IE567, 17H3384C9IE568, 16L1711C9IE589, 18K4093C9IE590, 19H4952C9IE515, 19F2183C9IE516, 19H4108C9IE517, 19H2616C9IE518, 19H3454C9IE519, 19F2181C9IE520, 18K1514C9IE521, 19F2182C9IE522, 19H4107C9IE523, 19F0992C9IE524, 18K4123C9IE525, 19E5708C9IE526, 19E5232C9IE527, 19F4232C9IE528, 19H2615C9IE529, 19H3455C9IE530, 19H4897C9IE531, 19B4591C9IE532, 19H3052C9IE533, 19A5788C9IE534, 19C7871C9IE535, 19D7958C9IE536, 19F5937C9IE537, 19G0615C9IE538, 19G1204C9IE539, 19G2208C9IE540,  19G3296C9IE541, 19G3421C9IE542, 19G3422C9IE543, 19G4536C9IE544, 19G4537C9IE545,  19G4558C9IE546,  19G4559C9IE547,  19G4952C9IE548, 19G5440C9IE549, 19G6408C9IE550, 19G7534C9IE551, 19G7535C9IE552, 19H3453C9IE553, 19H4278C9IE554, 19H4279C9IE555, 19H4576C9IE556, 19H4852C9IE557, 19H4979C9IE558, 19H4980C9IE559, 19H1215C9IE560, 19H4088C9IE561, 19H4577C9IE562, 19H4629C9IE563, 19H4851C9IE564, 19D7674C9IE569, 19E0233C9IE570, 19E2071C9IE571, 19E3052C9IE572, 19E3225C9IE573, 19F1089C9IE574, 19F2200C9IE575, 19F2671C9IE576, 19F3104C9IE577, 19F3918C9IE578, 19G1847C9IE579, 19G2531C9IE580, 19G3645C9IE581, 19G4535C9IE582, 19G5986C9IE583, 19G7857C9IE584, 19H4280C9IE585, 19H4977C9IE586, 19H4978C9IE587, 19H5135C9IE588, 16D6106C9IE663, 13F0021C9IE664, 16H4826C9IE665, 16D5894C9IE666, 17H3096C9IE667, 16L1621C9IE669, 16L5518C9IE670, 16D6018C9IE671, 16D5650C9IE672, 16L1991C9IE673, 19B4446C9IE674, 19B4688C9IE675, 19B4986C9IE676, 18K3870C9IE677, 18K3871C9IE678, 18K4092C9IE679, 16D5646C9IE668, 19G4709C9IE614, 19H3229C9IE615, 19F2792C9IE616, 19G5683C9IE617, 19H5127C9IE618, 19H1069C9IE619, 19G7575C9IE620, 19G3288C9IE621, 19G4825C9IE622, 19H5594C9IE623, 19G5931C9IE624, 19H1879C9IE625, 19H3228C9IE626, 19H3411C9IE627, 19G7011C9IE628, 19H5561C9IE629, 19H1821C9IE630, 19H6164C9IE631, 19G7183C9IE632, 19H5126C9IE633, 19G6820C9IE634, 19G7770C9IE635, 19H1313C9IE636, 19G4710C9IE637, 19H3410C9IE638, 19E7223C9IE639, 19E7681C9IE640, 19E7683C9IE641, 19F0124C9IE642, 19F0125C9IE643, 19F1681C9IE644, 19F3419C9IE645, 19F5330C9IE646, 19F6909C9IE647, 19H2571C9IE648, 19H2617C9IE649, 19H2618C9IE650, 19H3133C9IE651, 19H3134C9IE652, 19H3194C9IE653, 19H3195C9IE654, 19H4838C9IE655, 19H4839C9IE656, 19H5434C9IE657, 19H5435C9IE658, 18B1255C9IE659, 18E5617C9IE660, 18F1781C9IE661, 18G3000C9IE662, 19C5822C9IE680, 19F0295C9IE681, 19F1376C9IE682, 19F2066C9IE683, 19F2165C9IE684, 19F2744C9IE685, 19F2993C9IE686, 19F3375C9IE687, 19F3533C9IE688, 19F4913C9IE689, 19F4964C9IE690, 19F5200C9IE691, 19F5203C9IE692, 19G1871C9IE693, 19G3427C9IE694, 16D5343C9IE881, 19F4265C9IE861, 19H1168C9IE862, 19F1979C9IE863, 19F4530C9IE864, 19H1167C9IE865, 19G4646C9IE866, 19G6005C9IE867, 19G2290C9IE868, 19H1330C9IE869, 19G7319C9IE870, 19G5686C9IE871, 19F4442C9IE872, 19H0088C9IE873, 19F3924C9IE874, 19H5212C9IE875, 19G7395C9IE876, 19G7497C9IE877, 19G4517C9IE878, 19F4443C9IE879, 19G3952C9IE880 
FEI Number 3003902943
Recalling Firm/
Manufacturer		 Taewoong Medical Co., Ltd.
14 Gojeong-ro, Wolgot-Myeon,
Gimpo-Si,
Gyeonggi-Do Korea (the Republic of)
Manufacturer Reason
for Recall		Misprinted IFUs shipped with esophageal stents
FDA Determined
Cause 2		Error in labeling
ActionOn 10/18/19, an Esophageal Stent Device Return notices were emailed to the U.S. distributor who was asked to stop releasing products. The distributor was further asked to do the following for products already distributed: please send customers a notification to stop using the product immediately and to return affected product. Then the distributor was asked to return all affected products in their possession including returned products to the manufacturer. e-mail contact: bclee@stent.net
Quantity in Commerce178
DistributionU.S.: IN
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = ESW
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