Events

Recall of Hipstar V40 Femoral Stem

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
    45334
  • Event Risk Class
    Class 2
  • Event Number
    Z-0473-2008
  • Event Date Posted
    2007-12-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66615
  • 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
    Femoral Stem - Product Code LPH
  • Reason
    Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Action
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.

Device

Hipstar V40 Femoral Stem
  • Model / Serial
    Lot Numbers: G1370631, G1514925, G1567981, and  G1621024
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA
  • Product Description
    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-011, IMPLANT SIZE 11 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA