Events

Retiro De Equipo (Recall) de CPT 12/14

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 Zimmer, 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
    66500
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1032-2014
  • Fecha de inicio del evento
    2013-10-11
  • Fecha de publicación del evento
    2014-02-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-04-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124899
  • 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/polymer, cemented - Product Code JDI
  • Causa
    Zimmer recently conducted a review of all historic packaging validations at its zimmer manufacturing b.V. (zmbv) facility in ponce, puerto rico. based on this review, it was determined that the packaging operations conducted in the building 1 packaging operation at this facility were not properly validated. as a result, zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. the acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. these packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the zmbv facility building 1 packaging operations.
  • Acción
    Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.

Device

CPT 12/14
  • Modelo / Serial
    60225078 60261757 60274775 60310767 60398002 60491038 60638468 60638470 60685165 60776190 60797319 60927586 61189804 61237349 61342952 61468762 61490103 61596784 61748948 61764725 61840597 61917999 61964635 61999588 62003977 60261761 60261763 60776227 60776234 60846362 60916726 60952935 60979483 61162865 61189800 61356814 61460831 61523005 61739387 61748949 61829563 61996730 60310780 60335521 60412478 60457571 60533531 60776287 60776288 60823773 60990055 61045309 61351320 61500146 61727738 61727739 61957411 60217292 60245136 60330281 60448728 60491098 60648441 60704737 60748770 60776312 60797325 60916737 60952946 61261797 61293863 61307997 61733348 61758312 61868121 61881187 61885896 61991679 62001331 60245153 60245154 60323912 60372490 60589471 60704749 60723802 60748790 60921196 60957269 61045290 61061843 61104280 61114610 61733350 61987756 61991676 60217518 60310793 60330358 60589477 60789763 60829712 60957183 60957252 61010390 61047782 61356826 61484547 61589156 61650372 61696379 61747548 61762055 61774068 61783714 61878465 61930415 61991684 61999776 62003973 62006549 62006552 62014206 60509163 61130729 61460829 61613256 61711999 62097052 60600577 60704770 60898905 61035924 61045315 61114612 61237346 61243405 61516824 61596779 61744474 61833302 61878466 61930418 61964629 60310799 60352497 60600588 60615058 60748834 60797333 60823790 60889814 60889815 60952953 60957186 60979502 61045316 61325399 61336846 61351344 61522157 61694927 61762060 61815831 62001327 60261985 60261986 60326340 60330332 60510215 60574913 60685247 60748844 60748850 60797335 60799614 60822508 60916748 60916749 60921201 60944305 61075599 61114637 61460856 61472388 61731627 61762053 61833303 61840602 61884450 61957405 62001329 60380023 60443946 60491173 60685261 60809480 61024361 61104288 61516832 61607601 60378595 60723862 60748854 60748855 60898910 61045291 61114614 61211994 61505499 61512550 61814507 61914812 61987765 60200828 60225125 60274811 60510226 60660270 60685253 60723871 60748857 60822510 60842663 60889819 60889820 61027639 61061835 61182969 61282937 61314041 61460835 61490099 61696376 61731630 61809118 61987773 62017570 60217523 60274812 60420451 60517574 60704826 60704827 60723878 60749232 60789777 60809481 60809482 60898877 60927619 60927620 60979509 61002485 61045318 61173152 61205952 61216685 61490100 61505498 61650364 61696373 61744461 61762059 61833301 62005396 60491175 60704843 60789778 60799619 60880782 60997430 61546126 60324107 60443947 60704844 60724240 60809483 60921203 61114628 61601357 60491179 60820144 61061846 61290086 61546128 61691513 60225115 60330349 60723884 60723885 60809484 61027640 61061855 61500145 61579869 61817968 61927037 60510237 60510239 60704831 60749247 60749248 60820124 60858530 60889822 60990042 60990043 61006802 61045292 61094975 61114629 61316307 61354857 61647194 61696371 61744471 61820815 369396 60222666 60274815 60510242 60589746 60660275 60704835 60749255 60749256 60944307 60973154 60979538 61024369 61024370 61062535 61114616 61153032 61339722 61550881 61683768 61696359 61779345 61820816 369397 60225128 60704836 61024371 61066495 61490101 61790493 60704845 60777781 60803456 61770622 60789779 60979539 61664275 60704715 61035926 61075584 61325390 61520903 61636260 61762068 61878931 61993208 60809444 61061836 61297358 61473756 61522154 61589113 61790499 61993210
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
  • Descripción del producto
    CPT 12/14 COCR (various sizes)
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA