Events

Retiro De Equipo (Recall) de Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''.

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 Linvatec Corp..

¿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
    31392
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1551-05
  • Fecha de inicio del evento
    2005-02-22
  • Fecha de publicación del evento
    2005-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37794
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
  • Causa
    Linvatec has determined there is a possibility the pouch tyvek header to foil longitudinal seal was not properly sealed by bemis flexible packaging, in all pouches, prior to sterilization by linvatec. therefore there is a potential for compromised sterility of the devices.
  • Acción
    Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.

Device

Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''RE...
  • Modelo / Serial
    Lot #''s BBB32078, BBB34094, BBB34999, BBB35880, BBB38626, BBB48838, BBB49880, BBB59210, BBB53860, BBB55923, BBB59491, BBB65474, BBB66408, BBB68488, BBB31428, BBB34095, BBB35002, BBB36673, BBB48839, BBB51999, BBB55022, BBB59493, BBB66410, BBB35055, BBB50780, BBB61023, BBB34089, BBB35879, BBB37714, BBB48840, BBB52911, BBB55921, BBB65475, BBB30602, BBB31323, BBB49881, BBB52912, BBB67472, BBB52000.
  • Clasificación del producto
    Orthopedic Devices
  • Distribución
    Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
  • Descripción del producto
    Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''.
  • Manufacturer
    Linvatec Corp.

Manufacturer

Linvatec Corp.
  • Dirección del fabricante
    Linvatec Corp., 11311 Concept Blvd, Largo FL 33773-4908
  • Source
    USFDA