Events

Recall of GCA (Gravity Compensating Accessory)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50065
  • Event Risk Class
    Class 1
  • Event Number
    Z-0458-2009
  • Event Initiated Date
    2008-10-03
  • Event Date Posted
    2008-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74612
  • Notes / Alerts
    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.
  • Extra notes in the data
    Central Nervous System Fluid Shunt and Components - Product Code JXG
  • Reason
    Integra neurosciences has become aware that certain gravity compensating accessory implants have the potential for csf leakage under certain conditions.
  • Action
    Urgent: Product Recall Notification letters, dated 10/3/08, were sent out on October 9, 2008. Letters explain the reason for the recall and the catalog and lot numbers affected. If the product has been implanted, it is recommended that the patient be monitored periodically using the standard of care determined appropriate by the patient's attending physician. If the product is found in inventory, customers are asked to quarantine the product and contact their Integra Sales Rep for assistance and for arrangements for product return. A Recall Acknowledgement and Return Form is to be completed and returned to Integra for reconciliation purposes.

Device

GCA (Gravity Compensating Accessory)
  • Model / Serial
    Catalog number: 903-430, Lot Numbers 148792, 149247; Catalog Number 903-435, Lot Numbers 147796, 148790; Catalog Number 903-440; and Lot Numbers 147795, 149246
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - MI, IL, NY, IN, CA, IN and NC and Carnegie, Victoria, Melbourne, Australia.
  • Product Description
    Gravity Compensating Accessory; || High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. || Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France; || distributed by: Integra NeuroSciences, Plainsboro, NJ 08536 || The GCA is an implantable device designed to be used in conjunction with implanted systems which shunt cerebrospinal fluid CSF from the cerebral ventricles to an appropriate drainage site.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.