Events

Recall of Device Recall Foundation Baseplate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Encore Medical, Lp.

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
    53981
  • Event Risk Class
    Class 2
  • Event Number
    Z-0622-2010
  • Event Initiated Date
    2009-12-03
  • Event Date Posted
    2010-01-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86982
  • 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
    Knee Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis - Product Code JWH
  • Reason
    Product does not meet specifications for a size 8 right foundation tibia baseplate.
  • Action
    Firm notified consignees by an Urgent Field Safety Notice dated 12/3/2009. The letter identified the product, stated the problem, and the risk associated with the problem. Customers are to immediately return the affected product and notify all of their customers if product was further distributed. Customers are to complete and return the enclosed response form. Questions should be directed to David Harris, Manager of Customer Service at 512-834-6330 or Valerie Moulton, International Customer Service at 512-834-6275.

Device

Device Recall Foundation Baseplate
  • Model / Serial
    Lot number 53986069
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey.
  • Product Description
    Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate intraoperatively.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Manufacturer Address
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA