Events

Recall of 700 CX / CXM INFLATABLE PENILE PROSTHESIS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by AMERICAN MEDICAL SYSTEMS CANADA INC..

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
    42738
  • Event Risk Class
    III
  • Event Initiated Date
    2014-10-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Lightning bolt keith needle assembly may have needles found in 3 lots that appear to be missing a bend near the eyelet which may lead to an increased rate of bent or broken needles. these are found in ams 700 series inflatable penile prosthesis accessory kit.

Device

700 CX / CXM INFLATABLE PENILE PROSTHESIS
  • Model / Serial
    Model Catalog: 72401850 (Lot serial: 884422018); Model Catalog: 72401850 (Lot serial: 865869024); Model Catalog: 72401850 (Lot serial: 886858011); Model Catalog: 72401850 (Lot serial: 886858004); Model Catalog: 72401850 (Lot serial: 884422015)
  • Product Description
    700 CX / CXM INFLATABLE PENILE PROSTHESIS
  • Manufacturer
    AMERICAN MEDICAL SYSTEMS CANADA INC.

Manufacturer

AMERICAN MEDICAL SYSTEMS CANADA INC.
  • Manufacturer Address
    GUELPH
  • Source
    HC