Events

Retiro De Equipo (Recall) de Device Recall Conserve Cups

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por MicroPort Orthopedics Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    75063
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0688-2017
  • Fecha de inicio del evento
    2016-06-21
  • Fecha de publicación del evento
    2016-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149420
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    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
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Descripción del producto
    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.