Events

Recall of Device Recall Integra NeuroSciences Combo Kit

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
    58490
  • Event Risk Class
    Class 3
  • Event Number
    Z-2194-2011
  • Event Initiated Date
    2011-02-22
  • Event Date Posted
    2011-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99461
  • 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
    Drills, burrs, trephines & accessories (manual) - Product Code HBG
  • Reason
    Outer packaging of combo kit was mislabeled with an incorrect lot number.
  • Action
    Integra LifeSciences Corp. sent a " Urgent Product Recall Notification" letter dated February 22, 2011, to the only affected consignee. It was reported the Combo Kits of SPOO98 / INS- 4500 ( Hermetic Large Style Ventricular Catheter set and drill set for NY) - Catalog # 31046 Lot Number 171237, Outer packages were labeled incorrectly. The customer was advised to return this, and they would be replaced with correctly labeled product. The issue is easily recognizable, and does not pose a safety risk to patients. An acknowledgement form was included to be returned to Integra. Further information is available at 609-936-2485.

Device

Device Recall Integra NeuroSciences Combo Kit
  • Model / Serial
    Lot 171237
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- including the state of New York.
  • Product Description
    Integra NeuroSciences, Combo Kit, Lot 171237, Integra LifeSciences 3498 West 2400 South, West Valley City, UT 84119. || A kit for cranial access containing multiple necessary components to create the burr hole which is used to gain access to the cranial vault for the purpose of providing a portal for catheter placement.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.