Events

Retiro De Equipo (Recall) de Trilogy Conventional Polyethylene Liners

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-1023-2014
  • 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=124867
  • 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, porous uncemented - Product Code LPH
  • 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

Trilogy Conventional Polyethylene Liners
  • Modelo / Serial
    61547919 61954158 61241463 61821673 62188365 61564304 60919205 61666604 60928241 62086340 62296755 60611445 60841757 60863748 61187640 61224727 61261826 62062929 62173370 60550153 60588810 60828784 61018862 61110916 61159634 62296754 60576173 61209715 61564309 60575226 60595581 60623653 60749578 62316407 60611447 61255394 61364450 61382532 60611244 60817929 60863723 60563186 62268497 61547941 62137191 61892712 61901662 60668061 61584777 61059234 61403759 60497031 61303608 61875716 62087621 62138394 61906179 61919744 61853252 60945780 61403762 61868301 62123088 62330868 61552276 60973584 61159666 61209871 61491267 61731038 61906430 62154608 60806194 60940002 61092880 62304925 61598585 61698771 61712665 61902214 62148657 60612251 60658071 60980492 61072064 61160052 61261860 61642713 61722445 62296659 60715034 61018915 61036921 61136634 61179946 61377132 61504792 61564330 61598593 61652828 61662223 61746897 61885964 61902215 62062927 62166311 62166312 62167440 60664534 60611465 61121730 61491274 61542625 62170707 62296657 62304924 61138050 61392960 61509276 61591304 61662225 61751908 61875723 61885967 61902216 62113239 62183216 62308937 62322488 60715040 60715041 62134061 62292055 61407093 61509275 61564339 61598601 61751904 61928945 62183217 62292053 62330877 61575699 61403906 60699177 61591302 62127617 62301528 60545115 61504789 61698789 61863756 62109142 62296661 61261880 61403757 62123083 62296662 60595588 61407096 61633829 61788072 62296663 60593824 60841777 61424558 62268509 61509269 61580668 61631807 62330880 61234865 61286973 61521041 62049367 61241564 61542576 61751903 62147386 61478541 60588818 62118728 61403756 61598607 62044858 62329122 61547934 62147387 61478392 61575705 61788071 62329128 61712669 61005950 60945793 60595589 61765738 61036924 61668359 61478415 62330884 61110936 61675948 61138057 62301533 60717011 60611470 60656941 60863743 62330885 60715052 61287001 61751907 60600334 62296665 62327789 61651457 62292056 60862307 62077408 62180255 62296658 62000454 62127618 61651453 61547925 60612264 62123082 61224783 60595598 61652830 61765723 61005427 60584587 61547937 60643575 60885073 61623060 60885074 61641918 61241575 61261913 61643326 60642954 61461428 61457271 60676424 60767532 61436014
  • 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 CUP NEUTRAL LINER || MODULAR CUP 10 DEGREE LIN || MODULAR CUP 20 DEGREE LIN || MODULAR CUP 7MM OFFSET LI
  • 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