Events

Device Recall Conserve Cups 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MicroPort Orthopedics Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    75063
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0688-2017
  • 사례 시작날짜
    2016-06-21
  • 사례 출판 날짜
    2016-12-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-07-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149420
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • 원인
    Revision rate trends from within the microport orthopedics inc. database evaluated for the modular head metal on metal tha systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head conserve(r) systems and dynasty(r) metal acetabular liner systems.
  • 조치
    MicroPort sent an Urgent Field Safety Notice dated June 22, 2016, to all affected customers notifying them of the change in the instructions for use on July 7th, 2016 by email. The firm also notified US hospitals where the implantation surgeries occurred within the last twelve (12) months by letter on July 13th, 2016 delivered by FedEx Priority. Customers were asked to complete and return the enclosed form even if they do not have any affected product to return by fax to 1-901-451-6032 or PostMarket@ortho.microport.com. For questions regarding this recall call 901-867-4771.

Device

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.

Manufacturer

MicroPort Orthopedics Inc.