Events

Recall of Device Recall Galileo Femoral Clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Plus Orthopedics USA.

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
    36234
  • Event Risk Class
    Class 3
  • Event Number
    Z-0149-2007
  • Event Initiated Date
    2006-06-20
  • Event Date Posted
    2006-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48230
  • 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
    Femoral Clamp - Product Code HAW
  • Reason
    Manufacturer recall of the device due to the possibility of pressure plate fractures/breakage.
  • Action
    Notification will take place to the wholesale (agent) level via telephone calls from PLUS USA''s Customer Service Department on/or about June 20, 2006. Each location will be contacted to determine if they have any affected devices. If so, they will be issued an RMA with the request to return any affected devices as soon as possible. Returned devices will be sent to the manufacturer for repair.

Device

Device Recall Galileo Femoral Clamp
  • Model / Serial
    All units
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide including states of AZ, CA, CO, ID, NY, TX, VA & WI
  • Product Description
    Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

Plus Orthopedics USA
  • Manufacturer Address
    Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
  • Source
    USFDA