Events

Recall of Device Recall AMS DURAII Distil Tips

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

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
    37615
  • Event Risk Class
    Class 2
  • Event Number
    Z-0702-2007
  • Event Initiated Date
    2007-02-19
  • Event Date Posted
    2007-04-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51067
  • 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
    Penile Prosthesis Tip Extenders - Product Code FAE
  • Reason
    Mis-labeling: the dura-ii 2 cm universal tips and the dura-ii 4 cm distal tips were incorrectly labeled with the opposite labels.
  • Action
    The consignees were notified of the recall by letter starting Feb 7, 2007. Consignees were asked to return product to American Medical Systems.

Device

Device Recall AMS DURAII Distil Tips
  • Model / Serial
    Lot 475177
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN
  • Manufacturer
    American Medical Systems

Manufacturer

American Medical Systems
  • Manufacturer Address
    American Medical Systems, 10700 Bren Rd W, Minnetonka MN 55343-9679
  • Source
    USFDA