Events

Retiro De Equipo (Recall) de Device Recall BlackMax Motor Systems, MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, Emax2Plus M

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
    65863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0199-2014
  • Fecha de inicio del evento
    2011-05-06
  • Fecha de publicación del evento
    2013-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120536
  • 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, pneumatic powered & accessory/attachment - Product Code HSZ
  • Causa
    Anspach effort, inc. palm beach gardens, fl initiated a correction of its medical device labeling for its pneumatic systems operating manual, cutting burr chart and product catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th.
  • Acción
    The firm, Anspach Effort, Inc., sent an "Urgent Medical Device Labeling Correction" letter dated June 27, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Destroy or delete any items in their inventory immediately and replace with the attached revised Operating Manual, Product Catalog and/or Cutting Bur Chart. 2) Complete and return the attached Customer Reply Form indicating disposition of the labeling materials and confirming their receipt of this letter, and fax to 1-800-327-6661. 3) If they distributed any of the products to other services or facilities, please forward this information as appropriate. For additional copies, contact Anspach Customer Support at (800) 327-6887.

Device

Device Recall BlackMax Motor Systems, MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Sy...
  • Modelo / Serial
    part number 20-0019
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.
  • Descripción del producto
    Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. || Product Usage: Indication for use is cutting and shaping bone
  • 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