Events

Retiro De Equipo (Recall) de Device Recall Poly Component Trial, UCCS

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 Medtronic Sofamor Danek USA 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
    76694
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1514-2017
  • Fecha de inicio del evento
    2017-02-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153923
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    The dovetails of poly trials, beta 2.0, were observed as either cracked or broken.
  • Acción
    Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197.

Device

Device Recall Poly Component Trial, UCCS
  • Modelo / Serial
    Lot Numbers: a) REF 90-SRK-170310, TU53733-01 b) REF 90-SRK-170312, TU53736-01 c) REF 90-SRK-170314, TU53737-01 d) REF 90-SRK-170410, TU53733-02 e) REF 90-SRK-170412, TU53736-02 f) REF 90-SRK-170414, TU53737-02 g) REF 90-SRK-170510, TU53733-03 h) REF 90-SRK-170512, TU53736-03 i) REF 90-SRK-170514, TU53737-03 j) REF 90-SRK-170610, TU53733-04 k) REF 90-SRK-170612, TU53736-04 l) REF 90-SRK-170614, TU53737-04
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US distribution to AR, MA
  • Descripción del producto
    Poly Component Trial, UCCS, packaged in the following sizes and configurations: || a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310 || b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312 || c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314 || d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410 || e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412 || f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414 || g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510 || h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512 || i) Poly Comp Trial - UCCS 5x14, REF 90-SRK-170514 || j) Poly Comp Trial - UCCS 6x10, REF 90-SRK-170610 || k) Poly Comp Trial - UCCS 6x12, REF 90-SRK-170612 || l) Poly Comp Trial - UCCS 6x14, REF 90-SRK-170614 || The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA