Events

Retiro De Equipo (Recall) de Bearing Sleeve with Removable Bur Guard

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
    63793
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0783-2013
  • Fecha de inicio del evento
    2012-09-05
  • Fecha de publicación del evento
    2013-02-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114783
  • 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
    Burr, Orthopedic - Product Code HTT
  • Causa
    Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. the materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.
  • Acción
    The firm, Anspach Effort, Inc. sent an "URGENT: Medical Device Removal" letter dated November 7, 2012, to its customer. The letter identified the product, problem and actions to be taken. The customer was instructed to do the following: 1) Screen their inventory and remove and return all products immediately. 2) Complete and return the attached Customer Reply Form via fax or email to the address provided on the form. Should the customer have any questions, please contact Anspach Product Support at (800) 327-6887.

Device

Bearing Sleeve with Removable Bur Guard
  • Modelo / Serial
    Lot number: 2000930
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed in the state of Massachusetts
  • Descripción del producto
    Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
  • Manufacturer
    The Anspach Effort, Inc.

Manufacturer

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