Events

Recall of Device Recall LEGION Pressfit Stem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew Inc.

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
    52582
  • Event Risk Class
    Class 2
  • Event Number
    Z-1820-2009
  • Event Initiated Date
    2009-01-22
  • Event Date Posted
    2009-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83408
  • 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
    Products were mispackaged.
  • Action
    All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return.

Device

Device Recall LEGION Pressfit Stem
  • Model / Serial
    Lot Number: 06DM08612.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France.
  • Product Description
    LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. || The device is used for Orthopedic Knee Implants.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • Manufacturer Address
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA