Events

Retiro De Equipo (Recall) de Device Recall Restoration

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 Stryker Howmedica Osteonics.

¿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
    28052
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0571-04
  • Fecha de inicio del evento
    2003-12-30
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31115
  • 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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
  • Causa
    Restoration t3 revision hip system distal stem has demonstrated fractures.
  • Acción
    Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.

Device

Device Recall Restoration
  • Modelo / Serial
    All Lots
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The following direct accounts received the device: Branches/Agencies: 46; Hospitals: 526; Government Hospitals: 23; International Distributors: 10; Latin America: 3; Canada: 1; and Asia Pacific: 3.
  • Descripción del producto
    Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. || 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; || 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; || 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; || 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; || 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; || 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; || 6260-3-020 T3 MOD REV DIST STM 20MMX225MM; || 6260-3-022 T3 MOD REV DIST STM 22MMX225MM; || 6230-3-024 T3 MOD REV DIST STM 24MMX225MM; || 6260-3-114 T3 MOD REV DIST STM 14MMX265MM; || 6260-3-115 T3 MOD REV DIST STM 15MMX265MM; || 6260-3-116 T3 MOD REV DIST STM 16MMX265MM; || 6260-3-117 T3 MOD REV DIST STM 17MMX265MM; || 6260-3-118 T3 MOD REV DIST STM 18MMX265MM; || 6260-3-119 T3 MOD REV DIST STM 19MMX265MM; || 6260-3-120 T3 MOD REV DIST STM 20MMX265MM; || 6260-3-122 T3 MOD REV DIST STM 22MMX265MM; || 6260-3-124 T3 MOD REV DIST STM 24MMX265MM; || 6260-3-214 KINKED T3 DIST STM 14MMX265MM; || 6260-3-215 KINKED T3 DIST STM 15MMX265MM; || 6260-3-216 KINKED T3 DIST STM 16MMX265MM; || 6260-3-217 KINKED T3 DIST STM 17MMX265MM; || 6260-3-218 KINKED T3 DIST STM 18MMX265MM; || 6260-3-219 KINKED T3 DIST STM 19MMX265MM; || 6260-3-220 KINKED T3 DIST STM 20MMX265MM; || 6260-3-222 KINKED T3 DIST STM 22MMX265MM; || 6260-3-224 KINKED T3 DIST STM 24MMX265MM; || 6260-3-314 KINKED T3 DIST STM 14MMX305MM; || 6260-3-315 KINKED T3 DIST STM 15MMX305MM; || 6260-3-316 KINKED T3 DIST STM 16MMX305MM; || 6260-3-317 KINKED T3 DIST STM 17MMX305MM; || 6260-3-318 KINKED T3 DIST STM 18MMX305MM; || 6260-3-319 KINKED T3 DIST STM 19MMX305MM; || 6260-3-320 KINKED T3 DIST STM 20MMX305MM; || 6260-3-322 KINKED T3 DIST STM 22MMX305MM; || 6260-3-324 KINKED T3 DIST STM 24MMX305MM; || LR3ST RESTORATION REV HIP SYS SURGICAL TECHNIQUE; || 6262-7-000-0 RESTORATION REV HIP SYS TEMPLATE SET FOR STRAIGHT STEMS ONLY; || LTEM71 1-9 RESTORATION REV HIP SYS 265MM BOWED STEM TEMPLATES; || LTEM72 1-9 RESTORATION REV HIP SYS 305MM BOWED STEM TEMPLATES.
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Dirección del fabricante
    Stryker Howmedica Osteonics, 300 Commerce Ct, Mahwah NJ 07430-2104
  • Source
    USFDA