Events

Retiro De Equipo (Recall) de Device Recall Ossur Total Knee

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 Ossur North America 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
    35132
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1200-06
  • Fecha de inicio del evento
    2006-03-29
  • Fecha de publicación del evento
    2006-07-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45391
  • 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
    Joint, Knee, External Limb Component - Product Code ISY
  • Causa
    The company's initiation of the recall is based on a finding that some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
  • Acción
    On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.

Device

Device Recall Ossur Total Knee
  • Modelo / Serial
    Serial numbers: 6918 ¿ 7569
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
  • Descripción del producto
    Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • Dirección del fabricante
    Ossur North America Inc, 27412 Aliso Viejo Pkwy, Aliso Viejo CA 92656-3371
  • Source
    USFDA