Events

Recall of Device Recall Penile Prosthesis

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
    49376
  • Event Risk Class
    Class 2
  • Event Number
    Z-2461-2008
  • Event Initiated Date
    2008-07-17
  • Event Date Posted
    2008-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73227
  • 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 inflatable implant. - Product Code JCW
  • Reason
    The carton labeling does not match the product packaged inside. the package indicated that the device is an 18cm preconnected ms pump while it is actually an 18cm ultrex preconnected ms pump.
  • Action
    On July 17, 2008, the physician who implanted the device received a phone call from AMS to discuss the event and be sure he understands what went wrong (Ultrex cylinders implanted instead of CX) and any new risks introduced to his patient so he can properly assess any impact it may have. A follow up letter " AMS Important Product Recall" dated July 21, 2008 was also sent to document the event and the call. The letter requested to return of the "Recall Acknowledgement Form". The second physician (tried not used) has already returned the device and will not receive further communication. A complaint was assigned to document the event.

Device

Device Recall Penile Prosthesis
  • Model / Serial
    Lot # 551668
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    LA
  • Product Description
    AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-20, Manufacture Date 2008 Jun 20.
  • Manufacturer
    American Medical Systems

Manufacturer

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