Events

Retiro De Equipo (Recall) de Device Recall Gliding Nail Radiolucent Guide instrument set

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 Plus Orthopedics USA.

¿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
    35054
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0928-06
  • Fecha de inicio del evento
    2006-02-22
  • Fecha de publicación del evento
    2006-06-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45198
  • 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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
  • Causa
    Plus usa has been informed by plus ag that the accuracy of the instrument set may be affected in some cases. it is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.
  • Acción
    There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The firm telephoned agents beginning February 22, 2006, requesting return of the devices. Returned Material Authorizations have been issued (March, 2006) for consigned inventory in the field with instructions given to remove and return affected units immediately. All returns to PLUS Orthopedics USA have been appropriately quarantined and segregated to prevent unintended use or shipment.

Device

Device Recall Gliding Nail Radiolucent Guide instrument set
  • Modelo / Serial
    Revision A Serial Number: None
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The 5 sets were distributed in the following states: 1) California, 2) Idaho, and 3) New York.
  • Descripción del producto
    Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument: || 1130020-A: GNp Carbon Targeting Handle || 1130021-A: GN Adapter Screw for Handle SW 10 || 1130022-A: GN Targeting Guide Carbon 125¿ || 1130023-A: GN Targeting Guide Carbon 135¿ || 1130060-A: GNp Drill Guide Locking No. 3 || 1133158-A: GN Centering Sleeve New Guide || Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

Plus Orthopedics USA
  • Dirección del fabricante
    Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
  • Source
    USFDA