Events

Recall of Device Recall Component of Ortho Development Balanced Knee Modular Tibial System.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ortho Development Corporation.

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
    51926
  • Event Risk Class
    Class 2
  • Event Number
    Z-1229-2010
  • Event Initiated Date
    2009-03-19
  • Event Date Posted
    2010-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83873
  • 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
    Tibial Augment 5mm Block - Product Code JWH
  • Reason
    A component of knee prosthesis was assembled incorrectly.
  • Action
    E-mail was sent to all agents and distributors on March 19, 2009 with illustrations and instructions on how to detect the upside down assembly and how to correct the problem if detected during surgery. Direct questions to the Ortho Development Corporation by calling 1-801-619-3444.

Device

Device Recall Component of Ortho Development Balanced Knee Modular Tibial System.
  • Model / Serial
    Serial Numbers: 567-5101; 567-5102; 567-5103; 567-5104; 567-5105; 567-5106; 567-5201; 567-5202; 567-5203; 567-5204; 567-5205 and 567-5206.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States (AZ, FL, OR, TX and UT) and Japan.
  • Product Description
    5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. || The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision procedures where other treatments or devices have failed.
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Manufacturer Address
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • Manufacturer Parent Company (2017)
    Ortho Development Corporation
  • Source
    USFDA