Events

Recall of Device Recall Scorpio NRG

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    50102
  • Event Risk Class
    Class 2
  • Event Number
    Z-1141-2010
  • Event Initiated Date
    2007-08-20
  • Event Date Posted
    2010-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74725
  • 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
    A box labeled as a scorpio nrg femoral size 7 right, may actually contain a scorpio ps femoral size 5 right.
  • Action
    Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.

Device

Device Recall Scorpio NRG
  • Model / Serial
    Product Code: 814407R; Lot Code: L65MKD
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product went to 2 US Stryker branches.
  • Product Description
    Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. || Mahwah, NJ
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA