Events

Retiro De Equipo (Recall) de Device Recall Triathlon PKR Insert X3 1

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 Stryker Howmedica Osteonics Corp..

¿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
    50535
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0869-2009
  • Fecha de inicio del evento
    2008-11-25
  • Fecha de publicación del evento
    2009-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75714
  • 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
    Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis - Product Code HRY
  • Causa
    Label mix-up: stryker orthopaedics became aware of a lot for lot mix up between triathlon pkr insert x3 #1 lm/rl 8mm, 5630-g-108 lot code nxdmee and triathlon pkr insert x3 #1 rm/ll- 12 mm 5630-g-122 lot code m8jmee.
  • Acción
    Recall notifications entitled "URGENT PRODUCT RECALL" were sent via Federal Express on 11/25/2008 to Stryker branches, hospital risk management, Hospital Chief of Orthopaedics. For further information, please contact Stryker Howmedica Osteonics Corporation by telephone at 201-831-5718.

Device

Device Recall Triathlon PKR Insert X3 1
  • Modelo / Serial
    8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE; 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.
  • Descripción del producto
    Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE || Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE || Intended Use: || - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis || - Revision of previous unsuccessful surgical procedures, either involving, or || not involving, previous use of a unicompartmental knee prosthesis || - As an alternative to tibial osteotomy in patients with unicompartmental || osteoarthritis, where bone stock is of poor quality or inadequate for other || reconstructive techniques as indicted by deficiencies of the femoral || condyle/tibia plateau. || These components are intended for implantation with bone cement. || Stryker Orthopaedics; || Howmedica Osteonics Copr. || 325 Corporate Drive || Mahwah, NJ 07430
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA