Events

Retiro De Equipo (Recall) de Device Recall ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM

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
    50901
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1354-2009
  • Fecha de inicio del evento
    2009-01-06
  • Fecha de publicación del evento
    2009-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77624
  • 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
    Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Causa
    Product deviation : specific lots of sprayed ha hip stems did not meet stryker's internal material specification for tensile bond strength and crystallinity.
  • Acción
    An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.

Device

Device Recall ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
  • Modelo / Serial
    Item Number Description Lot Number 6020-0130 ACCOLADE 132 SIZE 1 25107601 6020-0130 ACCOLADE 132 SIZE 1 25370101 and 6020-0130 ACCOLADE 132 SIZE 1 25370103.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Accolade TMZF Hip Stem; Hydroxylapatite Coated, Titanium Plasma Spray, V40 Taper, Sterile. 132 degree neck angle. || Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
  • 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