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Devices
Device Recall Conserve Cups
모델명 / 제조번호(시리얼번호)
REF 38BF3642 Serial Numbers: 1380112, 1399025, 1402166, 1340677, 1427276, 1429743 REF 38BF3642SP Serial Number 1416590 REF 38BF3844 Serial Numbers: 1368260, 1402167, 1399026, 1380113, 1418795 REF 38BF3844SP Serial Number 1416814 REF 38BF4046 Serial Numbers: 1368261, 1380114, 1402168, 1399027, 1418796, 1429744, 1449113 REF 38BF4046SP Serial Number 1416950 REF 38BF4248 Serial Numbers: 1397139, 1368262, 1381417, 1399029, 1422026, 1418797, 1433514, 1449114, 1452995 REF 38BF4248SP Serial Number 1416816 REF 38BF4450 Serial Numbers: 1380115, 1399031, 1399231, 1373711, 1366654, 1418948, 1433515, 1431187, 1449115, 1482461, 1484998 REF 38BF4450SP Serial number 1416563 REF 38BF4652 Serial Numbers: 1380116, 1395709, 1368263, 1373712, 1399233, 1427277, 1429745, 1433516, 1445264, 1449116, 1460186, 1460187, 1482463, 1481980 REF 38BF4652SP Serial Numbers: 1417403, 1417616 REF 38BF4854 Serial Numbers: 1381418, 1399234, 1373904, 1368264, 1399235, 1427278, 1431188, 1433517, 1445265, 1460189, 1460188, 1468891, 1481979, 1484999 REF 38BF5056 Serial Numbers: 1381419, 1399236, 1373905, 1368265, 1397140, 1402169, 1413708, 1427279, 1445266, 1449117, 1452997, 1468892, 1468893, 1476014, 1476013, 1482462, 1571773, 1571772, 1650637, 1650638, 1651368 REF 38BF5258 Serial Numbers: 1397141, 1399237, 1368266, 1380117, 1422025, 1431189, 1445267, 1449118, 1452996, 1468894, 1476016, 1482460, 1481456, 1571771, 1571770, 1589362, 1650639 REF 38BF5258SP Serial numbers: 1416945 REF 38BF5460 Serial Numbers: 1368267, 1380118, 1397142, 1399238, 1402170, 1429746, 1433518, 14335181454410, 14335181454409, 1452478, 1476017, 1481978, 1484997, 1651370 REF 38BF5460SP Serial Number 1416944 REF 38BF5662 Serial Numbers: 1368268, 1381420, 1399239, 1422021, 1431190, 1452994, 1484996 REF 38BF5662SP Serial Number 1416957 REF 38BF5864 Serial Numbers: 1368269, 1402171, 1380124, 1399240 REF 38BF5864SP Serial Number 1416589 REF 38BF6066 Serial Numbers: 1399241, 1402172, 1380125, 1427280 REF 38BF6066SP Serial Number 1416815 REF 38QH3644 Serial Numbers: 098450454, 098450453 REF 38QH3846 Serial Numbers: 087448320, 087448319, 028455786, 108636368, 039752495, 089843391, 1283757 REF 38QH4048 Serial Numbers: 087448317, 087448318, 078573304, 108636369, 039753686 REF 38QH4250 Serial Numbers: 087447402, 087447838, 038474921, 088573305, 019741984, 039783429 REF 38QH4452 Serial Numbers: 087446899, 087447160, 058552436, 029746761, 069832435 REF 38QH4654 Serial Numbers: 036310979, 036312725, 066322950, 087445485, 087445891, 058533122, 088584084, 029751144, 059832434, 099864589,109864590 REF 38QH4856 Serial Numbers: 036308619, 036312726, 066322951, 087443056, 087444883, 038510025, 058552900, 128691657, 039763773 REF 38QH5058 Serial Numbers: 036303438, 036310069, 066322952, 087424788, 087444884, 038515854, 088584085, 029746762, 059832436, 059832438, 1322641 REF 38QH5260 Serial Numbers: 036310978, 036312727, 087445887, 087446423, 088552437, 128688680, 059831040 REF 38QH5462 Serial Numbers: 036311691, 066322954, 087445888, 087446426, 028469801, 058552901, 128691658, 029763769, 059838299 REF 38QH5664 Serial Numbers: 087446896, 087447161, 058544859, 118691659, 029751973, 059829624 REF 38QH5666 Serial Numbers: 087447403, 087447839, 058544860, 128691660, 059830306 REF 38SC3650 Serial Numbers: 025149290, 025160237, 025174327, 075208859, 085242413, 085246262, 105249039, 016300068, 026305920, 096368471, 126385423, 027393904, 087458988, 068573306, 108602432, 029744514 REF 38SC3852 Serial Numbers: 025149144, 025170078, 025160238, 035179216, 075232801, 075242414, 085246264, 105267353, 115277853, 026301520, 026317024, 036319642, 056329110, 106333747, 027385922, 107460700, 107465345, 118703700 REF 38SC4054 Serial Numbers: 025149111, 025160239, 035179223, 075236081, 085242415, 085246267, 115276025, 016277854, 036318111, 036318361, 066320283, 097438943, 127465344, 108566756, 029753065 REF 38SC4256 Serial Numbers: 025149838, 025146436, 025179217, 035188989, 075233865, 085242416, 095257911, 105268093, 105269854, 125277855, 125283868, 036318819, 066320284, 106368472, 097460701, 097480974, 038466319, 019746760 REF 38SC4458 Serial Numbers: 025144180, 025146460, 035179222, 035188990, 075233866, 085242417, 085249038, 105269855, 115276026, 115283869, 026305908, 056320285, 106336785, 027385923, 077437212, 107460702, 107461472, 029566757 REF 38SC4660 Serial Numbers: 025142838, 025146459, 025174328, 035188992, 035179221, 075233867, 085242418, 095262956, 105269857, 016283870, 036319135, 046320286, 066341722, 106368473, 116371016, 037389856, 037387396, 077432335, 107465343, 108492001, 019745503 REF 38SC4862 Serial Numbers: 025144201, 025140464, 025190407, 025170075, 025170076, 075233868, 085242419, 105262954, 105269861, 016283871, 036319136, 066320287, 087459243, 108605237, 029745502 REF 38SC5064 Serial Numbers: 025128517, 025150758, 025160240, 025170072, 025170074, 035188993, 035190419, 085242420, 085248657, 105263392, 105269867, 016283872, 066320288, 077438092, 068493738, 108605238 REF 38SC5266 Serial numbers: 025190387, 025128518, 025160241, 035179218, 035188994, 035192254, 085242421, 085248658, 105269869, 036319137, 027389086, 087438091, 107465342 REF 38SC5468 Serial Numbers: 025190390, 025128519, 025160242, 025174329, 025187586, 035190750, 075188995, 075192255, 085242394, 095248659, 105274072, 106331324, 077436606, 018495671 REF 38SC5670 Serial Numbers: 025179948, 025190082, 025179949, 025128520, 025155250, 025160243, 035179219, 085242422, 085248660, 105269872, 116331326, 107460703 REF 38SC5672 Serial Numbers: 025190391, 025190397, 025190398, 025155817, 025158548, 025160244, 035188996, 035179220, 075204364, 085242423, 095248661, 026302015, 027394748, 107460704, 028486699
의료기기 분류등급
Orthopedic Devices
의료기기 등급
2
이식된 장치?
Yes
유통
Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
제품 설명
Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, || REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF5460SP, REF 38BF5662, REF 38BF5662SP, REF 38BF5864, || REF 38BF5864SP, REF 38BF6066, REF 38BF6066SP, REF 38QH3644, REF 38QH3846, REF 38QH4048, REF 38QH4250, REF 38QH4452, REF 38QH4654, REF 38QH4856, REF 38QH5058, || REF 38QH5260, REF 38QH5462, REF 38QH5664, REF 38QH5666, REF 38SC3650, REF 38SC3852, || REF 38SC4054, REF 38SC4256, REF 38SC4458, REF 38SC4660, REF 38SC4862, REF 38SC5064, REF 38SC5266, REF 38SC5468, REF 38SC5670, REF 38SC5672 || For use with the conserve metal head
Manufacturer
MicroPort Orthopedics Inc.
1 Event
Device Recall Conserve Cups 의 리콜
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제조사
MicroPort Orthopedics Inc.
제조사 주소
MicroPort Orthopedics Inc., 5677 Airline Rd, Arlington TN 38002-9501
제조사 모회사 (2017)
Shanghai Microport Medical (Group) Co. Ltd.
Source
USFDA
Language
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