Events

Retiro De Equipo (Recall) de Device Recall ConMed Linvatech Hall Surgical Blades, Sterile ST OSCIL BLD,ME92 COATED

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
    47848
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0389-2009
  • Fecha de inicio del evento
    2008-02-21
  • Fecha de publicación del evento
    2009-01-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70456
  • 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
    Surgical Instrument Motors and Accessories/Attachments - Product Code GET
  • Causa
    Sterility compromised. there is a possibility that certain catalog number and lots of conmed linvatec hall surgical blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.
  • Acción
    An Urgent Medical Device Recall letter was issued. Customers must check their facility's inventory immediately for the catalog and lot numbers in the attached list. They also need to complete and sign the enclosed Reply Form and mail or fax the Reply Form to ConMed Linvatec using the enclosed self addressed postage paid envelope or fax 727-319-5701. Customers have an option to either re-sterilize the products using the re-sterilization instructions in the letter or they can return the devices to ConMed Linvatec for a credit using the enclosed preprinted FedEx Air Bill with ConMed Linvatec's Bill Number and the return goods number. Recall is being conducted to the distributor and end user level.

Device

Device Recall ConMed Linvatech Hall Surgical Blades, Sterile ST OSCIL BLD,ME92 COATED
  • Modelo / Serial
    BBD23695, BBD29401, BBD31989, and BBD35721.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD,ME-92 COATED, Catalog # 00507116600 || ConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries. These blades are designed to cut bone in an oscillating plane.
  • Manufacturer
    Linvatec Corp.

Manufacturer

Linvatec Corp.
  • Dirección del fabricante
    Linvatec Corp., 11311 Concept Boulevard, Largo FL 33773
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA