Events

Retiro De Equipo (Recall) de Device Recall FPS 35mm x 3.5 mm nonlocking screw

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 Ortho Solutions 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
    74849
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2835-2016
  • Fecha de inicio del evento
    2016-07-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148595
  • 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
    Screw, fixation, bone - Product Code HWC
  • Causa
    Mislabeling of a single batch of fps 3.5 x 35 mm locking screw as being non-locking screws.
  • Acción
    Ortho Solutions sent a "Field Safety Notice" letter dated July 21, 2016 to their affected customers. The letter identify the Solutions Business Development Manager will contact the customer to arrange for the isolation and removal of the unused product from their inventory. Replacement product will be provided. The customer was advised to passed on the "Field Safety Notice" to all who need to be aware within their organization and to any organization to which their have further distributed or transferred the affected screw. Upon removal of the affected device, customers are asked to please sign and return the "Field Safety Corrective Action Declaration Form", by which to confirm they have received the "Field Safety Notice" and that they declare that the required recall has been completed at their hospital. For further questions, call (201) 258-7305.

Device

Device Recall FPS 35mm x 3.5 mm nonlocking screw
  • Modelo / Serial
    Part number - OS326835 Lot number: 10100/269A12-68051
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution
  • Descripción del producto
    FPS 35mm x 3.5 mm non-locking screw
  • Manufacturer
    Ortho Solutions Inc

Manufacturer

Ortho Solutions Inc
  • Dirección del fabricante
    Ortho Solutions Inc, 330 Franklin Tpke, Mahwah NJ 07430-3524
  • Empresa matriz del fabricante (2017)
    Ortho Solutions Inc.
  • Source
    USFDA