Recall of Device Recall Like Universal Sling Bar

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

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
    38194
  • Event Risk Class
    Class 2
  • Event Number
    Z-1118-2007
  • Event Initiated Date
    2007-06-13
  • Event Date Posted
    2007-07-23
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-10-20
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Sling Bar - Product Code FRW
  • Reason
    Sling bar may have a center bolt break at the adapter while in use.
  • Action
    Liko Inc notified distributors and end users by letter on 6/13/07.

Device

  • Model / Serial
    Serial Numbers: 1200101 through 1201281
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Liko Universal Sling Bar 450 R2R || Product NUmber: 3156095
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Liko, Inc., 122 Grove Street, Suite 201, Franklin MA 02038
  • Source
    USFDA