Events

Recall of Device Recall Foundation Knee Revision 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
    54197
  • Event Risk Class
    Class 2
  • Event Number
    Z-0826-2010
  • Event Initiated Date
    2009-12-11
  • Event Date Posted
    2010-02-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87810
  • 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 joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis - Product Code JWH
  • Reason
    Partial lot of product was not manufactured to specification. central locking screw was missing threads. there is a potential for dissociation because the screw is not able to be used as a secondary fixation method.
  • Action
    Firm notified consignees by letter on 12/11/2009. The letter informs physicians that patients with implanted devices should counseled about the issue and should report any changes to their treating physician.

Device

Device Recall Foundation Knee Revision Baseplate
  • Model / Serial
    Lot 53944312
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, FL, GA, CA, AZ, Japan
  • Product Description
    Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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