Events

Recall of Device Recall AMS 700 Penile Prothesis

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
    37437
  • Event Risk Class
    Class 2
  • Event Number
    Z-0785-2007
  • Event Initiated Date
    2007-02-09
  • Event Date Posted
    2007-05-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50551
  • 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 Prothesis - Product Code JCW
  • Reason
    The carton labeling does not match the product packaged inside.
  • Action
    AMS has contacted every account (via e-mail 2/9/2007) that either purchased or implanted the affected product. Unused pieces have been recovered and scrapped.

Device

Device Recall AMS 700 Penile Prothesis
  • Model / Serial
    Lot # 472642
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Canada and England.
  • Product Description
    AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Tactile Pump, 2 Cylinders.
  • Manufacturer
    American Medical Systems

Manufacturer

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