Events

Retiro De Equipo (Recall) de Device Recall Kelyniam CSI

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 Kelyniam Global, 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
    79791
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1871-2018
  • Fecha de inicio del evento
    2017-06-10
  • 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=163448
  • 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, cranioplasty, preformed, non-alterable - Product Code GXN
  • Causa
    Significant design changes made to the custom skull implant (csi) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to fda for marketing clearance. the temporal suture system (tss) is no longer being offered and the integrated fixation system (ifs) has been temporarily suspended.
  • Acción
    On June 10, 2017, the recalling firm notified its Sales Representatives that effective June 10, 2017, the firm would no longer offer the temporal suture system (TSS). The firm requested that sales reps dispose of all marketing materials which contain details regarding the TSS. Sales reps who wanted to keep existing booklets in the field were asked to contact the firm to obtain adhesive labels to place over the discontinued product. On November 13, 2017, the recalling firm notified its Sales Representatives that the firm was temporarily suspending shipment of the Integrated Fixation System (IFS). The firm stated that all paper brochures were to be discarded, and asked sales reps to inform all those who received "Customize Skull and Craniofacial Implants" brochure and IFU. Revised marketing materials are available on the firm's website, www.kelyniam.com. If you have any questions, you may contact Dr. Mark V. Smith, Vice President of Kelyniam Global, Inc., at msmith@kelyniam.com, or by phone at (800) 280-8192 x702.

Device

Device Recall Kelyniam CSI
  • Modelo / Serial
    Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C.  Case Numbers: CSI082114-CT1 CSI081214-TB1 CSI020216-LK1 CSI092016-LD1R CSI100116-BM1A CSI092616-YB1 CSI092616-MM1 CSI112316-YB1 CSI050217-LS1 CSI052217-AF1 CSI062317-GM1 CSI071017-NS1B CSI071417-CM1 CSI102617-DL1 CSI101617-JF1A CSI102617-DL1
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US nationwide distribution.
  • Descripción del producto
    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
  • Manufacturer
    Kelyniam Global, Inc.

Manufacturer

Kelyniam Global, Inc.
  • Dirección del fabricante
    Kelyniam Global, Inc., 97 River Rd, Collinsville CT 06019-3246
  • Empresa matriz del fabricante (2017)
    Kelyniam Global, Inc.
  • Source
    USFDA