Events

Retiro De Equipo (Recall) de Moore Cemented

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-1035-2014
  • 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=124902
  • 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, femoral component, cemented, metal - Product Code JDG
  • 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

Moore Cemented
  • Modelo / Serial
    60169597 365445 60096116 60096117 60134409 60845244 61059560 61613250 366221 60096118 60553617 60743729 60990038 61298521 365622 60096119 60411949 60501830 60540531 60609946 60700469 61657255 365458 60110443 60154855 60187556 60301871 60484369 60590160 60716272 60768572 60887301 61118584 61211680 61304669 61589078 61619986 366386 60096121 60124827 60169413 60242838 60301886 60411970 60484390 60540735 60565849 60610009 61122126 61401537 61694181 61878452 61934378 61992515 365461 366387 367572 60109037 60110290 60124913 60169470 60204787 60242845 60326542 60395275 60423101 60474918 60484409 60768593 60845456 61199171 61298517 61613251 61817985 61992516 365499 367548 369841 60096125 60110448 60148883 60242895 60293315 60484704 60540826 60581312 60737211 61103540 61324218 61619209 61659604 61758278 61817987 366388 369882 60109039 60124924 60134410 60169479 60187599 60242901 60293321 60335415 60442118 60506747 60993378 60993379 61118585 61276626 61398796 61651794 61756168 61758280 60096126 60187653 60412010 60537009 60574597 60787916 61118586 61932403 366389 369842 60124934 60187682 60274760 60423134 60980807 61231910 61651793 61837093 365464 365604 60096127 60355236 60540889 60565935 61662668 61976171 365444 60085816 60148884 60484813 61042186 61290074 61528630 61744433 60301911 60541000 61059561 61555631 61658313 366382 60154916 60395295 60900095 61324217 60096128 60541001 61370524 365448 60096186 60553915 61496597 60096187 60096188 366307 60096189 60096190 60166763 367542 60110458 60301876 60906529 60169412 60326978 60484392 61895487 60099418 60242846 60506729 60096192 60096193 365496 60523403 60331362 365481 366300 61222214 365500 60906530 61886563 366301 60096195 60484817 61886564 365449 366304 60423158 60906531 60096202 60331367 365616 366578 367657 369317 60101998 60101999 60113196 60113197 60145797 60156493 60178358 60187897 60213589 60274027 60284125 60284126 60294382 60313728 60382721 60411695 60467652 60474624 60614956 60708479 60793758 60822078 60822089 60876798 60899020 61092517 61104296 61172285 61199985 61243392 61282926 61293847 61336987 61435528 61555658 61664257 61696348 369400 60102000 60102001 60113198 60135105 60135108 60156495 60156496 60178359 60187902 60213591 60222247 60234255 60273998 60275695 60294383 60313730 60313732 60324334 60345750 60382722 60411698 60457745 60474626 60535059 60551516 60589262 60708480 60793770 60822079 60822090 60876799 60899021 61092518 61172276 61172277 61199987 61263822 61282922 61293846 61337003 61435527 61460812 61522994 61550878 61555659 61696349 365615 365617 369401 60145802 60187905 60324336 60429016 60474628 60474629 60803409 61115345 61351331
  • 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
    MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
  • 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