Events

Retiro De Equipo (Recall) de OSCILLATING SAW ATTACHMENT

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 The Anspach Effort, Inc..

¿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
    78901
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0398-2018
  • Fecha de publicación del evento
    2018-01-11
  • 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=160829
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Causa
    This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
  • Acción
    On November 15, 2017 the firm sent letter to their only consignee. Our records show that your facility has received the product subject to this removal. 1. Immediately review your inventory to identify and quarantine the affected product listed above in a manner that ensures the affected product will not be used. 2. Review, complete, sign and return the attached reply form on page 3 of this letter to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification. 3. Return the affected product as soon as possible, but within 30 business days. 4. Forward this notice to anyone in your facility who needs to be informed. 5. If the affected product has been forwarded to another facility, contact that facility to arrange its return. 6. Maintain awareness of this notice until the product has been returned. 7. Keep a copy of this notice. We apologize for any inconvenience that this product recall (removal) may create and appreciate your cooperation with our request. Should you have any inquiries please do not hesitate to contact your DePuy Synthes sales consultant. Thank you for your attention and cooperation. For further questions, please call (610) 314-2106.

Device

OSCILLATING SAW ATTACHMENT
  • Modelo / Serial
    Catalog ID: 532.021 VET  Serial #: 190673
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Internationally to Canada
  • Descripción del producto
    OSCILLATING SAW ATTACHMENT || Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

The Anspach Effort, Inc.
  • Dirección del fabricante
    The Anspach Effort, Inc., 4500 Riverside Dr, Palm Beach Gardens FL 33410-4235
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA