Events

Retiro De Equipo (Recall) de Device Recall Advent

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 Dental 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
    28217
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1139-04
  • Fecha de inicio del evento
    2004-01-13
  • Fecha de publicación del evento
    2004-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-09-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31392
  • 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
    Implant, Endosseous, Root-Form - Product Code DZE
  • Causa
    Sterility barrier compromised.

Device

Device Recall Advent
  • Modelo / Serial
    Advent Implant Line   Part # Description Lot Number Quantity AVACT Scr, Tapered Abut, AdVent 013789 299 AVACT Scr, Tapered Abut, AdVent 015135 166 AVACT Scr, Tapered Abut, AdVent 015548 499 AVACT Scr, Tapered Abut, AdVent 016679 229 AVACT Scr, Tapered Abut, AdVent 017539 300 AVACT Scr, Tapered Abut, AdVent 017539 100 AVACT Scr, Tapered Abut, AdVent 0202675 197 AVACT3 Abut, Tapered, AdVent, 3.0mm Imp 017540 50 AVACT3 Abut, Tapered, AdVent, 3.0mm Imp 0200281 70 AVACT3 Abut, Tapered, AdVent, 3.0mm Imp 0202676 69 AVB10 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 10mm 013555 318 AVB10 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 10mm 016159 401 AVB10 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 10mm 0201977 295 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 014357 143 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 014869 149 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 015474 100 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 016160 389 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 017701 255 AVB13 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 13mm 0202330 197 AVB16 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 16mm 016161 200 AVB16 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 16mm 0202621 86 AVB8 Imp, AV, SBM, 3.7mm, 4.5mm Interface, 8mm 0200502 49 AVBA Abut, Ball, Advent, 1mm 012719 149 AVBA Abut, Ball, Advent, 1mm 013557 260 AVBA Abut, Ball, Advent, 1mm 015192 98 AVBA Abut, Ball, Advent, 1mm 015389 310 AVBA Abut, Ball, Advent, 1mm 016162 300 AVBA Abut, Ball, Advent, 1mm 016458 200 AVBA Abut, Ball, Advent, 1mm 016593 296 AVGA Abut, Gold, Friction-Fit, Advent 015472 100 AVGA Abut, Gold, Friction-Fit, Advent 016592 50 AVGA Abut, Gold, Friction-Fit, Advent 016916 150 AVGA Abut, Gold, Friction-Fit, Advent 0201251 47 AVGA Abut, Gold, Friction-Fit, Advent 0202678 68 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 013175 251 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 014836 174 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 016064 161 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 016566 245 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 016815 80 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 017438 87 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 017702 261 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 0201825 85 AVH10 Imp, AV, HA, 3.7mm, 4.5mm Interface, 10mm 0202331 87 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 013176 357 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 014259 86 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 015986 83 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 016312 261 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 016343 153 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 016586 151 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 017558 147 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 017660 167 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 017705 94 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 0200271 89 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 0200503 94 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 0202196 153 AVH13 Imp, AV, HA, 3.7mm, 4.5mm Interface, 13mm 0202889 71 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 013790 160 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 015107 123 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 016587 88 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 016910 74 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 0200116 82 AVH16 Imp, AV, HA, 3.7mm, 4.5mm Interface, 16mm 0202506 70 AVH20/4 Abut, 20 deg, AdVent Imp 012524 69 AVH20/4 Abut, 20 deg, AdVent Imp 014803 50 AVH20/4 Abut, 20 deg, AdVent Imp 015948 28 AVH20/4 Abut, 20 deg, AdVent Imp 017358 297 AVH8 Imp, AV, HA, 3.7mm, 4.5mm Interface, 8mm 014358 50 AVH8 Imp, AV, HA, 3.7mm, 4.5mm Interface, 8mm 015469 48 AVH8 Imp, AV, HA, 3.7mm, 4.5mm Interface, 8mm 016163 209 AVH8 Imp, AV, HA, 3.7mm, 4.5mm Interface, 8mm 016163 100 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 013320 66 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 013493 480 AVHL/4 Abut.Hex-Lock, AdVent, 4.5mm Flare 015497 321 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 016653 106 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 017686 150 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 017686 50 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 0200504 199 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 0201249 50 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 0201724 198 AVHL/4 Abut, Hex-Lock, AdVent, 4.5mm Flare 0202569 199 AVHL/6 Abut, Hex-Lock, AdVent, 6.5mm Flare 016344 51 AVHL/6 Abut, Hex-Lock, AdVent, 6.5mm Flare 017688 50 AVHL/6 Abut, Hex-Lock, AdVent, 6.5mm Flare 0200995 50 AVHL/6 Abut, Hex-Lock, AdVent, 6.5mm Flare 0201603 74 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 013177 300 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 015316 300 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 016746 96 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0200429 245 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0200429 -245 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0200429 245 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0200996 95 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0202306 194 AVIT/4 Transfer, Indirect, AdVent, 4.5mm Flare 0204454 70 AVPC Coping, Plastic Castable, Advent Imp 0200200 95 AVPC Coping, Plastic Castable, Advent Imp 0202543 50 AVR Replica, AdVent Implant 012358 270 AVR Replica, AdVent Implant 014243 400 AVSC Scr, Surgical Cover, Ti, Flat, AdVent Imp 014983 200 AVWB10 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 10mm 015090 223 AVWB10 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 10mm 017730 150 AVWB10 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 10mm 0200997 48 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 014609 49 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 015045 50 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 015045 235 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 016762 120 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 0200505 147 AVWB13 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 13mm 0201863 146 AVWB16 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 16mm 016184 100 AVWB8 Imp, AV, SBM, 4.7mm, 4.5mm Interface, 8mm 0202663 100 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 012366 100 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 014359 49 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 014870 201 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 017592 60 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 017661 72 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 017762 67 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0200632 76 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0200684 78 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0201944 56 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0202010 70 AVWH10 Imp, AV, HA, 4.7mm, 4.5mm Interface, 10mm 0204366 87 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 012854 262 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 016267 27 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 016929 52 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 017009 59 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 017482 143 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 0200123 50 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 0201325 85 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 0201663 183 AVWH13 Imp, AV, HA, 4.7mm, 4.5mm Interface, 13mm 0202045 86 AVWH16 Imp, AV, HA, 4.7mm, 4.5mm Interface, 16mm 014419 47 AVWH16 Imp, AV, HA, 4.7mm, 4.5mm Interface, 16mm 016164 57 AVWH16 Imp, AV, HA, 4.7mm, 4.5mm Interface, 16mm 0200779 90 AVWH16 Imp, AV, HA, 4.7mm, 4.5mm Interface, 16mm 0202300 44 AVWH8 Imp, AV, HA, 4.7mm, 4.5mm Interface, 8mm 0201329 50 AVWH8 Imp, AV, HA, 4.7mm, 4.5mm Interface, 8mm 0202664 87
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Descripción del producto
    Advent Implant Line
  • Manufacturer
    Zimmer Dental Inc

Manufacturer

Zimmer Dental Inc
  • Dirección del fabricante
    Zimmer Dental Inc, 1900 Aston Ave, Carlsbad CA 92008-7308
  • 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