Events

Retiro De Equipo (Recall) de Linear Straight Broach Handle, (Rasp Handle) EZ Clean" Linear Broach Handle

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 Greatbatch Medical.

¿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
    77120
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2055-2017
  • Fecha de inicio del evento
    2017-04-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154992
  • 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
    Broach - Product Code HTQ
  • Causa
    Greatbatch medical has voluntarily initiated a recall for the linear straight broach handle (rasp handle) and ez clean" linear broach handle. greatbatch medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use.
  • Acción
    Greatbatch sent an Urgent Medical Device Recall letter dated April 23, 2017. The letter described the product being recalled and described Reason For Recall, Risk To Health, Replacement Devices, & Instructions to DJO Surgical Inc. Advised consignee to quarantine and return the affected product. If the product was further distributed they should contact the end users and share the recall information with them. Requested consignees to complete and return the "Field Recall Response Form" to Stericycle at Greatbatch4053@stericycle.com or fax it to 877-479-8063. For questions contact your Greatbatch Medical representative, or contact us at 1-763-951-8235, or e-mail us at fieldaction.center@integer.net. For further questions, please call (763) 951-8184.

Device

Linear Straight Broach Handle, (Rasp Handle) EZ Clean" Linear Broach Handle
  • Modelo / Serial
    Lot numbers : Linear Straight Broach Handle (Rasp Handle): 2988946, 3138186, 3185601, 3287315, 3300879, 3333172, 3433392, 3332697. EZ Clean" Linear Broach Handle: 3508491.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the state of : TX
  • Descripción del producto
    Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059).
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Dirección del fabricante
    Greatbatch Medical, 2300 Berkshire Ln N, Plymouth MN 55441-4575
  • Empresa matriz del fabricante (2017)
    Integer Holdings Corporation
  • Source
    USFDA