Events

Recall of Device Recall 3DKNEE Tibial Insert Trial

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
    46960
  • Event Risk Class
    Class 2
  • Event Number
    Z-1539-2008
  • Event Initiated Date
    2008-02-20
  • Event Date Posted
    2008-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68630
  • 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 Prosthesis - Product Code JWH
  • Reason
    Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side.
  • Action
    Firm notified consignee by phone and asked them to return any outstanding product on 02/20/08.

Device

Device Recall 3DKNEE Tibial Insert Trial
  • Model / Serial
    Lot #53906407
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution --- country of Germany.
  • Product Description
    3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. || Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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