Events

Recall of Device Recall 3DKnee System

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
    56200
  • Event Risk Class
    Class 2
  • Event Number
    Z-2244-2010
  • Event Initiated Date
    2010-06-28
  • Event Date Posted
    2010-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92941
  • 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
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
  • Reason
    One lot of product has an incorrect color label. the color label is a secondary visual indicator of sizing.
  • Action
    Firm notified their consignees by letter on June 28, 2010.

Device

Device Recall 3DKnee System
  • Model / Serial
    Size 8, Left, Part # 333-01-108, Lot# A1000003
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Florida, Missouri, and Italy
  • Product Description
    3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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