Events

Retiro De Equipo (Recall) de ConMed Linvatec 9263A 4.2mm Sterling, Blade, Gator Meniscus Cutter

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 Linvatec Corp. dba ConMed Linvatec.

¿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
    56441
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2503-2010
  • Fecha de inicio del evento
    2010-08-05
  • Fecha de publicación del evento
    2010-09-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93673
  • 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
    Blade, Saw, General & Plastic Surgery, Surgical - Product Code GFA
  • Causa
    Conmed linvatec, largo, fl is recalling conmed linvatec 9263a,4.2mm sterling blade, gator meniscus cutter, lot number 178026 for breech in the sterile barrier.
  • Acción
    Recall Notifications will be sent to all direct consignees by FedEx, email, Fax, etc. If the account no longer has the product in their possession, they will be asked to respond as such. A Return Material Authorizations Number will be assigned for the returned product as required. Product returned will be placed into quarantine and will be dispositioned in accordance with ConMed Linvatec procedures. 100% of the consignees will be contacted. The reply form is the mechanism to verify notification effectiveness to all consignees. If a reply is not received within approximately 30 business days of the first notification ConMed Linvatec will make two additional contacts by phone and / or email, as necessary, to insure all consignees have received notification and have taken appropriate action. If a reply is not received following the third contact by email or phone, no further contacts will be made to the consignee.

Device

ConMed Linvatec 9263A 4.2mm Sterling, Blade, Gator Meniscus Cutter
  • Modelo / Serial
    Lot 178026
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Products were distributed to ConMed Linvatec consignees, sales representatives and affiliates within the US and Australia. US distribution was to WA, AZ, PA, KS, NM, UT, ID, IL. Products were distributed to ConMed Linvatec Australia.
  • Descripción del producto
    GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • Dirección del fabricante
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    USFDA