Events

Recall of Genesis Malleable Penile Prosthesis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Coloplast Manufacturing US, LLC.

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
    70960
  • Event Risk Class
    Class 2
  • Event Number
    Z-1538-2015
  • Event Initiated Date
    2015-04-09
  • Event Date Posted
    2015-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135724
  • 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
    Prosthesis, penile - Product Code FAE
  • Reason
    Several lots of the 9.5 mm genesis malleable penile prosthesis were mislabeled. the retail box and patient labels indicate a size 9 mm, instead of 9.5 mm. the device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.
  • Action
    Consignees were notified via Field Representatives starting on 4-9-2015 with a Coloplast "Urgent Correction Notification" letter dated April 7, 2015. The letter described the problem and the product involved in the recall. Requested consignees to complete the Return Form if returning inventory. For questions contact Customer Service at 800-258-3476.

Device

Genesis Malleable Penile Prosthesis
  • Model / Serial
    4336612, 4364589 , 4413811, 4413812, 4336613, 4413810.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
  • Product Description
    Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. || Product Usage: || The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
  • Manufacturer
    Coloplast Manufacturing US, LLC

Manufacturer

Coloplast Manufacturing US, LLC
  • Manufacturer Address
    Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
  • Manufacturer Parent Company (2017)
    Coloplast A/S
  • Source
    USFDA