Events

Retiro De Equipo (Recall) de Device Recall Swedevent

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-1143-04
  • 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=31396
  • 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 Swedevent
  • Modelo / Serial
    Swedevent Implant Line   Part # Description Lot Number Quantity ACBX2 ABUTMENT,SWEDE-VENT,BALL SCREW, 2MM 012689 70 ACBX2 ABUTMENT,SWEDE-VENT,BALL SCREW, 2MM 015188 50 ACBX2 ABUTMENT,SWEDE-VENT,BALL SCREW, 2MM 015778 69 ACBX2 ABUTMENT,SWEDE-VENT,BALL SCREW, 2MM 0200993 71 ACBX4 ABUT,SW-V,BALLSCREW,4.0MM 013174 100 ACBX4 ABUT,SW-V,BALLSCREW,4.0MM 015935 50 ACBX4 ABUT,SW-V,BALLSCREW,4.0MM 0200385 50 ACBX4 ABUT,SW-V,BALLSCREW,4.0MM 0201514 46 ACBX6 ABUT,SW-V,BALLSCREW,6.0MM 016063 33 ACTX3 ABUTMENT,SWEDE-VENT,COLLAR,3MM LONG 012349 75 ACTX3 ABUTMENT,SWEDE-VENT,COLLAR,3MM LONG 015137 50 ACTX3 ABUTMENT,SWEDE-VENT,COLLAR,3MM LONG 017685 50 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 012926 70 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 013745 47 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 015356 50 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 015496 147 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 0201165 70 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 0201943 55 ACTX6 ABUTMENT,SWEDE-VENT,TAPERED SCREW,6.0MM COLLAR 014046 56 AH20X ABUTMENT,PRE-ANGLE HEAD 20 DEG,SWEDE-VENT 013589 100 AH20X ABUTMENT,PRE-ANGLE HEAD 20 DEG,SWEDE-VENT 0203139 40 AH20X/5 ABUTMENT,PRE-ANGLE HEAD 20 DBL HEX,SWEDE-VENT 014278 100 AH20X/5 ABUTMENT,PRE-ANGLE HEAD 20 DBL HEX,SWEDE-VENT 016640 70 AH20X/5 ABUTMENT,PRE-ANGLE HEAD 20 DBL HEX,SWEDE-VENT 0202509 50 FMD Drill, Fixture Mount, Swede-Vent 012988 256 FMD Drill, Fixture Mount, Swede-Vent 013920 300 FMD Drill, Fixture Mount, Swede-Vent 014685 398 GPCA Coping, Gold, Sw-V, Ext Hex Imp 014769 139 GPCA Coping, Gold, Sw-V, Ext Hex Imp 015056 199 GPCA Coping, Gold, Sw-V, Ext Hex Imp 016643 134 GPCAS Scr, Replacement, Sw-V, Gold Coping 013922 100 GPCAS Scr, Replacement, Sw-V, Gold Coping 014614 500 HLAX/4 ABUTMENT,SWEDE-VENT, 013146 313 HLAX/4 ABUTMENT,SWEDE-VENT, 014223 300 HLAX/4 ABUTMENT,SWEDE-VENT, 016350 599 HLAX/5 ABUTMENT,SWEDE-VENT, 013310 149 HLAX/5 ABUTMENT,SWEDE-VENT, 014489 144 HLAX/5 ABUTMENT,SWEDE-VENT, 016845 215 HLAX/5 ABUTMENT,SWEDE-VENT, 017244 148 HLAX/6 ABUTMENT,SWEDE-VENT, 015824 50 HLAXS SCREW,SW-V,HEX-LOCK ABUT 013386 50 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 012895 100 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 014249 69 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 014753 150 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 015058 149 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 016720 99 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 013227 100 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 014250 199 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 014765 150 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 015536 148 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 017124 200 SCAX2 ABUT,SW-V,20DEG ANGLEBASE 016816 23 SCCX2 ABUTMENT,SWEDE-VENT, 015340 40 SCCX2 ABUTMENT,SWEDE-VENT, 015784 66 SCCX2 ABUTMENT,SWEDE-VENT, 0201264 72 TPCA ABUTMENT,SW-VENT COPING 0200400 30 TPCA ABUTMENT,SW-VENT COPING 0202433 31 TSA5 ABUTMENT,SW-V,COPING, 015797 30
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Descripción del producto
    Swedevent 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