Events

Retiro De Equipo (Recall) de Device Recall RibLoc System, Standard 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 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
    60286
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0336-2012
  • Fecha de inicio del evento
    2011-02-28
  • Fecha de publicación del evento
    2011-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104949
  • 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
    Ribloc screw from lot l1008007 was out of specification. it would not engage with the hex tip properly.
  • Acción
    The firm, ACUTE Innovation, sent an "URGENT NOTICE: DEVICE RECALL" letter dated February 21, 2011, to all consignees/customers via FED-EX on February 28, 2011. The letter describes the product, problem and actions to be taken. The customers were instructed to identify product having the lot code(s) and quarantine them; return all product from this lot to Acute Innovations immediately using shipping labels provided or return to: Acute Innovations, LLC, 21421 NW Jacobson Rd, Suite 700, Hillsboro, OR, 97124, and if they further distributed this product, notify those customers of this recall and request return of product(s). Customers can call ACUTE Innovation at 1-866-623-4137 for any questions about this recall.

Device

Device Recall RibLoc System, Standard Screw
  • Modelo / Serial
    lot L1008007; Part # RBP1202
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, GA, IL, MN, NC, NY, UT, and WA; and countries of: South Africa.
  • Descripción del producto
    10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. || The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY***NON STERILE***SCREW***ACUTE Innovations LLC 21421 NW Jacobson Road, Suite 700 Hillsboro, OR 97124 USA www.acuteinnovations.com*** MediMark Europe Sarl*** 11 rue Emile ZOLA BP 2332****38003 GRENOBLE CEDEX 2 FRANCE" || The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for the rib. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.
  • 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