Events

Retiro De Equipo (Recall) de Device Recall Anspach Pneumatic and Electric Motor Systems

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
    68496
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1983-2014
  • Fecha de inicio del evento
    2014-05-08
  • Fecha de publicación del evento
    2014-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128083
  • 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
    Several attachments and handpieces failed to meet the expected sterility assurance level (sal) when sterilized by the method that is specified in the current directions for use (dfu) provided with the device.
  • Acción
    Customers were notified 05/08/2014 by a Return Receipt Requested letter from Anspach with an URGENT: Medical Device Labeling Correction announcement, REGARDING: STERRAD 100S Hydrogen Peroxide Gas Plasma Technology no longer recommended for sterilization of Anspach products. The letter identified the problem and actions to be taken by the customer. Customers were to complete and return the attached reply form. If the products were distributed further, then those customers should have been notified as well. Customers were to contact Anspach Customer Support at 1-800-327-6887 if they want copies of the revised labeling.

Device

Device Recall Anspach Pneumatic and Electric Motor Systems
  • Modelo / Serial
    DFU:  18-0047: Revisions A & B  18-0074: Revision A; and  18-0105: Revisions A.  Operating Manuals:  19-0010: Revisions A, and  19-0013: Revisions A, B, & C.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, US Virgin Island and Guam; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Cameroon, Canada, Chile, Costa Rica, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Grand Cayman, Hong Kong, India, Israel, Jamaica, Japan, Korea, Lithuania, Malaysia, Mexico, Nassau, Netherlands, Nigeria, Palestine, Panama, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Descripción del producto
    Anspach Pneumatic and Electric Motor Systems. || Intended for cutting and shaping bone, including the spine and cranium.
  • 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