Events

Recall of Device Recall LiNA Loop

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

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
    58444
  • Event Risk Class
    Class 2
  • Event Number
    Z-2688-2011
  • Event Initiated Date
    2009-12-01
  • Event Date Posted
    2011-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99731
  • 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
    endoscopic electrocautery - Product Code KNF
  • Reason
    Potential for the lina loop to break during operating procedure.
  • Action
    Lina Medical Aps notified customers by newsletter in December 2009 followed by a letter to distributors including warnings added to instructions for use in January 2010.

Device

Device Recall LiNA Loop
  • Model / Serial
    Batch 7415, 8283, 8453, 9081
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    GA, MN, PA, WA, TN, MA, IN, Ontario Canada
  • Product Description
    LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.
  • Manufacturer
    LINA Medical ApS

Manufacturer

LINA Medical ApS
  • Manufacturer Address
    LINA Medical ApS, Formervangen 5, Glostrup Denmark
  • Manufacturer Parent Company (2017)
    Lina Ww Holding Ag
  • Source
    USFDA