Events

Recall of PSC Femoral Nonporous Rt Sz 6

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
    68029
  • Event Risk Class
    Class 2
  • Event Number
    Z-1610-2014
  • Event Initiated Date
    2014-04-01
  • Event Date Posted
    2014-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126817
  • 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
    A femoral component containing pegs was found in a box for the pegless version.
  • Action
    Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.

Device

PSC Femoral Nonporous Rt Sz 6
  • Model / Serial
    Lot No. A131876
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of NV, and AZ.
  • Product Description
    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • Manufacturer Address
    Ortho Development Corporation, 12187 Business Park Dr, Draper UT 84020-8663
  • Manufacturer Parent Company (2017)
    Ortho Development Corporation
  • Source
    USFDA