Events

Retiro De Equipo (Recall) de ACUTE Innovations Ribloc U plus Rib Fracture Plating System

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 ACUTE Innovations, LLC.

¿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
    67117
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0852-2014
  • Fecha de inicio del evento
    2013-10-30
  • Fecha de publicación del evento
    2014-01-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124733
  • 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
    Plate, fixation, bone - Product Code HRS
  • Causa
    The acute innovations ribloc u plus rib fracture plating system is recalled because it has the potential to malfunction during installation in a surgery.
  • Acción
    The firm sent the Urgent Notice: Device Recall letter, dated 30 Oct. 2013, to their consignees. The recall notification letter requested consignees to return the product to Acute and a return authorization number provided. Consignees should contact Acute Innovations Customer Service at 866-623-4137 for any questions regarding this recall notification.

Device

ACUTE Innovations Ribloc U plus Rib Fracture Plating System
  • Modelo / Serial
    LOT numbers:  RBL1301 for 50 mm Rib Plate: L1209002; L1302002;  L1308001;    RBL1302 for 75 mm Rib Plate: L1209003; L1302003;   RBL1303 for 115 mm Rib Plate: L1209004;  L1302004;  RBL1304 for 155 mm Rib Plate: L1209005;  RBL1305 for 215 mm Rib Plate: L1209006;
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
  • Descripción del producto
    The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. || The plates are manufactured from titanium and the screws are manufactured from titanium alloy. Surgical instrumentation is supplied with the implants in a surgical tray to facilitate the proper insertion of the plates and screws. || The ACUTE Innovations Modular RibLoc System is intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the ribs, and for reconstructions of the chest wall and sternum. || Part Numbers: || RBL1301- 50 mm Rib Plate; || RBL1302- 75 mm Rib Plate; || RBL1303- 115 mm Rib Plate; || RBL1304- 155 mm Rib Plate; || RBL1305- 215 mm Rib Plate;
  • Manufacturer
    ACUTE Innovations, LLC

Manufacturer

ACUTE Innovations, LLC
  • Dirección del fabricante
    ACUTE Innovations, LLC, 21421 NW Jacobson Rd Ste 700, Hillsboro OR 97124-9311
  • Empresa matriz del fabricante (2017)
    Acute Innovations Llc
  • Source
    USFDA