Events

Retiro De Equipo (Recall) de Device Recall DYONICSArthroscopic Blade

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 Ascent Healthcare Solutions.

¿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
    58937
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0947-2012
  • Fecha de inicio del evento
    2009-01-26
  • Fecha de publicación del evento
    2012-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100801
  • 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
    Arthroscope - Product Code HRX
  • Causa
    On 01/26/2009, ascent healthcare solutions, lakeland, fl initiated a recall of various models of dyonics, stryker, and linvatech reprocessed arthroscopic shaver blades. the sterility of the devices may be compromised due to a potential breach in the seal of the tyvek cover to the plastic tray.
  • Acción
    Ascent Healthcare Solutions sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated January 26, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to examine their inventory, remove and quarantine all affected devices. A Recall Effectiveness Check Form was attached for customers to complete and return via fax to 1-866-325-4760. Contact the firm at (888) 888-3433 ext. 5519 for questions regarding this recall.

Device

Device Recall DYONICSArthroscopic Blade
  • Modelo / Serial
    Lot numbers: 199468, 185659 and 197755.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, and WY, and the country of Canada.
  • Descripción del producto
    ***CAT 7205305***DYONICS***Arthroscopic Blade***3.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Beige***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 199468***Expiration Date: 12/2011. || ***CAT 7205306***DYONICS***Arthroscopic Blade***4.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Yellow***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 185659***Expiration Date: 08/2011. || ***CAT 7205307***DYONICS***Arthroscopic Blade***5.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Orange***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 197755***Expiration Date: 12/2011. || Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
  • Manufacturer
    Ascent Healthcare Solutions

Manufacturer

Ascent Healthcare Solutions
  • Dirección del fabricante
    Ascent Healthcare Solutions, 10232 S 51st St, Phoenix AZ 85044-5205
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA