Events

Recall of Balanced Knee 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
    27300
  • Event Risk Class
    Class 3
  • Event Number
    Z-0042-04
  • Event Initiated Date
    2003-09-15
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29660
  • 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
    The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
  • Action
    The firm has telephoned all distributors regarding the recall. An advisory note and product return request letters were sent to all distributors on 9/15/03.

Device

Balanced Knee System
  • Model / Serial
    Part # 252-0300, Lot # W007919.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in Japan.
  • Product Description
    Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Manufacturer Address
    Ortho Development Corporation, 12187 Business Park Drive, Draper UT 84020
  • Source
    USFDA