Events

Retiro De Equipo (Recall) de RTI Surgical Streamline OCT OccipitoCervicoThoracic Spinal Rod

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 RTI Surgical, Inc. (dba Pioneer Surgical Technology, 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
    75242
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0290-2017
  • Fecha de inicio del evento
    2016-09-16
  • Fecha de publicación del evento
    2016-10-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149750
  • 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, spinal interlaminal - Product Code KWP
  • Causa
    Rti surgical inc. (rti) is conducting a voluntary recall on two specific lots of the streamline¿ oct straight rod, cocr. 3.2mm (d) x 240mm (l) due to the potential for small cracks to be present on the rods. the small cracks on the rods used in implants could cause reduced strength of these affected implants, and lead to patient injury.
  • Acción
    RTI issued e-mail cutsomer notices for their voluntary recall of lots 234829 and 234829 of the Streamline¿ OCT Straight Rod, CoCr, 3.2mm (D) x 240mm (L) on 09/16/2016. RTI Surgical has produced replacement implants that have been verified as not containing any cracks. These implants will be sent to customers once they have identified how many replacements are needed. Please follow the below instructions. 1. Review inventory located in your facility and any other point of use locations that you may be responsible for. Immediately quarantine any implants listed in this recall notice. Please refer to the pictures included in customer notices for the etch location of the lot numbers for these implants: 2. Contact the RTI Surgical Field Inventory representative Jennifer Mannor so that replacements can be sent and an RGA and return shipping labels can be created if needed. 3. Review, complete and return the attached recall reply form to Dan Nelson (dnelson@rtix.com) in accordance with the directions on the business reply form within 5 business days of receipt of this notification. Should customers have any questions please do not hesitate to contact RTI Surgical Field Inventory representative Jennifer Mannor (Email: jmannor@rtix.com Phone: 906-225-5872.

Device

RTI Surgical Streamline OCT OccipitoCervicoThoracic Spinal Rod
  • Modelo / Serial
    Part Number: 23-CC-ROD-240; Lot Number: 234829, UDI Number: (01)0084646802 7179( 10}234829; Lot Number: 246678, UDI Number: {01}00846468027179{10}246678
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Nationwide Distribution in the states of: AL, CA, CO, FL, IN, IL, MI, MO, MS, NC, NY, OK, TN, TX, and VA,.
  • Descripción del producto
    RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) || Product Usage: || When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as defined by neck or back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/ dislocation, atlanto/axial fracture with instability, occipito-cervical dislocation, deformities or curvature, tumors, pseudoarthrosis, and revision of previous cervical and upper thoracic spine surgery. The occipital bone screws are limited to occipital fixation only. The use of the pedicle screws (standard and high angle) is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. The pedicle screws are not intended for use in the cervical spine. The hooks, connectors, and rods are also intended to provide stabilization to promote fusion following reduction of fracture/ dislocation or trauma in the cervical/ upper thoracic (C1-T3) spine.
  • Manufacturer
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)

Manufacturer

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
  • Dirección del fabricante
    RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), 375 River Park Cir, Marquette MI 49855-1781
  • Empresa matriz del fabricante (2017)
    RTI Surgical Inc
  • Source
    USFDA