Events

Recall of Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.

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
    34203
  • Event Risk Class
    Class 3
  • Event Number
    Z-0431-06
  • Event Initiated Date
    2005-11-28
  • Event Date Posted
    2006-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43267
  • 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
    Instrument, Ultrasonic Surgical - Product Code LFL
  • Reason
    Additional model 24khz tip sets were inadvertently packaged with the incorrect 35khz neuro flues. (2nd recall, same problem see z-141-6).
  • Action
    Customers were notified of the recall on 11/28/2005 via letter sent by UPS.

Device

Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip...
  • Model / Serial
    Lot 050678 and Lot 050575.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    The device is distributed nationwide to hospitals nationwide.
  • Product Description
    Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.