Events

Retiro De Equipo (Recall) de Device Recall Prima Plus

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 Keystone Dental 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
    80112
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2162-2018
  • 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=164567
  • 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
    Implant, endosseous, root-form - Product Code DZE
  • Causa
    The implants are mislabeled.
  • Acción
    The Firm sent an Urgent Medical Device Correction letter dated April 30, 2018. In this discrepancy, the 5 is missing from the implant length description. Please note this discrepancy is limited to the implant package label only. The patient chart labels are all correct. Keystone Dental has performed a thorough review and determined there are no health hazards associated with this issue. There is no issue with the product within the package and the product can be safely used without issue in accordance with the defined surgical protocols. There is no risk of confusion of product size. The diameter is correct. Prima Plus implants are only available in 11.5mm lengths. The catalogs, surgical protocols and manuals only define procedures and provide instrumentation for placing 11.5mm length implants. Additionally, the patient chart labels contained within the implant package are correct so that patient procedure history will be properly maintained. The issue is limited to the label on the outside of the product package only. The lot identified above is the only affected lot. No other lots are affected with this issue. The product referenced above can be used safely without issue and no further action is required. For further questions, please call (866) 902-9272.

Device

Device Recall Prima Plus
  • Modelo / Serial
    UDI: D76815737K0, Lot 37038
  • Clasificación del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
  • Descripción del producto
    Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K || Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
  • Manufacturer
    Keystone Dental Inc

Manufacturer

Keystone Dental Inc
  • Dirección del fabricante
    Keystone Dental Inc, 154 Middlesex Tpke, Burlington MA 01803-4403
  • Empresa matriz del fabricante (2017)
    Keystone Dental Inc
  • Source
    USFDA