Events

Retiro De Equipo (Recall) de Device Recall Jasper Vektor

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 TP Orthodontics, 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
    79739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1795-2018
  • Fecha de inicio del evento
    2018-05-01
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163889
  • 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
    Spring, orthodontic - Product Code ECO
  • Causa
    The firm has received 106 complaints of the device breaking in the patient's mouth. device breakage may cause injury to the patient.
  • Acción
    On May 3, 2018, the firm sent an Urgent Medical Device Recall letter to customers. The letter advised customers that the firm was voluntarily recalling Generation 1 Jasper Vektor Class 2 Correction Appliances due to receiving 106 customer complaints that the device had broken in the patient's mouth during placement and usage. Customers were instructed to do the following: 1. Locate any of the affected lots identified in the table below and quarantine the product. 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or refund, following the instructions below: Contact TP Orthodontics, Inc. at 800-338-8856 or info@tportho.com for a Return Goods Authorization and pre-paid shipping label. Alternately, use the carrier of your choice with available tracking and send to: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 3. Email, mail, or fax the attached response letter to TP Orthodontics, Inc. In addition to sending the letter back, you may call us with any questions or concerns. EMAIL: info@tportho.com FAX: 219-324-3029 MAIL: TP Orthodontics, Inc. ATTN: Recall Coordinator 100 Center Plaza La Porte, IN 46350 4. If you have any further questions or concerns after reviewing this notice, please contact TPO Customer Care Team 800-388-8856 or info@tportho.com

Device

Device Recall Jasper Vektor
  • Modelo / Serial
    25915000
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distributed to accounts in 20 states: AL, CA, CO, FL, HI, ID, IL, MA, ME, MI, NJ, NV, NY, OH, OR, PA, SC, TX, UT, and VA. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Germany, Spain, Finland, France, Great Britain, Hungary, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Portugal, Singapore, and South Africa.
  • Descripción del producto
    Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arch wire and stops.
  • Manufacturer
    TP Orthodontics, Inc.

Manufacturer

TP Orthodontics, Inc.
  • Dirección del fabricante
    TP Orthodontics, Inc., 100 Center Plz, La Porte IN 46350-9672
  • Empresa matriz del fabricante (2017)
    Tp Orthodontics, Inc.
  • Source
    USFDA