Events

Retiro De Equipo (Recall) de Device Recall DORO(R) Sterile Disposable Skull Pins

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 Pro-Med Instruments Gmbh.

¿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
    78501
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0193-2018
  • Fecha de inicio del evento
    2017-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159669
  • 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
    Holder, head, neurosurgical (skull clamp) - Product Code HBL
  • Causa
    The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. the breakage occurred at the very distal end of the conical part of the skull pin tip.
  • Acción
    Pro-Med Instruments Gmbh initiated their recall by email on October 30, 2017. The recall notice stated the following: " Actions to be taken by the customer I user: Review this notification and ensure that all users of the affected products are informed of this urgent field safety notice. If you have transferred the affected products to third parties, please forward a copy of this letter or inform the below mentioned contact person. Customers were instructed to check their stock for any affected products If you have any affected products on stock, please quarantine them and send the products back to us. You will receive a replacement as soon as we have received your "Acknowledgement and Receipt Form" and know your current stock. Check any products or records of the affected LOTs used prior to receipt of this field safety notice if the tips have been intact after the surgery. If the tips have not been intact, ensure that any remaining parts are removed from the patient. There are no further specific patient monitoring actions necessary related to this Field Safety Notice. If after reviewing this notification you have any further questions or queries please discuss them with your pro med instruments sales representative Please complete the attachment "Acknowledgement and Receipt Form" and return by Fax or email (see under nr. 8. below) to pro med instruments GmbH to confirm receipt by the 10th of November 2017 at the latest."

Device

Device Recall DORO(R) Sterile Disposable Skull Pins
  • Modelo / Serial
    Lots: 17041 and 17272
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada
  • Descripción del producto
    pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY || The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
  • Manufacturer
    Pro-Med Instruments Gmbh

Manufacturer

Pro-Med Instruments Gmbh