Events

Retiro De Equipo (Recall) de Device Recall 87k Arthroscopy Tubing Set

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
    56163
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2192-2010
  • Fecha de inicio del evento
    2010-07-06
  • Fecha de publicación del evento
    2010-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92773
  • 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
    Arthroscope - Product Code HRX
  • Causa
    Conmed linvatec largo, fl is recalling 87k arthroscopy tubing set, product number 87100, lots 0904151 to and including 1005201. product may have a breach in the seal that could potentially compromise the sterility of the contents.
  • Acción
    ConMed Linvatec Corporation sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 6, 2010, via FedEx next day delivery to all customers. The letter described the product, problem and action to be taken by customers within 30 days of receipt of the letter. The customers were asked to PLEASE DISCONTINUE USE OF THE IDENTIFIED PRODUCT WITH LOT NUMBERS BEGINNING WITH 0904151 THROUGH AND INCLUDING 1005201; to immediately check their inventory for the affected lots number and Do Not Use if they have any of the products; to complete and return a Reply Form and to notify their customers if the product was further distributed and return all unused affected product with lot codes starting 0904151 to and including 1005201, to ConMed Corporation, 525 French Road, Utica, NY 13502. On receipt, ConMed Linvatec will issue credit to customers. Should you have any additional questions, please contact our Customer Service department at 800-535-8536 or fax at 727-319-5701 or email: Custerserv1@linvatec.com

Device

Device Recall 87k Arthroscopy Tubing Set
  • Modelo / Serial
    Lot 0904151 through 1005201.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and Canada.
  • Descripción del producto
    REF 87100 87k Arthroscopy Tubing Set. For use with the 87k Arthroscopy Pump (87000). STERILE EO. Rx ONLY. Warning: Do not use this tubing set with any Small Joint Cannula System. || CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Made in USA. || The 87K Arthroscopy Tubing Set is designed for use with the 87K Arthroscopy Pump System. This system can be used in arthroscopic procedures using fluid irrigation for joint distension. This system may be used where gravity systems are currently in use such as knee, shoulder, ankle and elbow arthroscopy.
  • 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