Events

Recall of Device Recall 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
    49484
  • Event Risk Class
    Class 2
  • Event Number
    Z-0227-2009
  • Event Initiated Date
    2008-08-20
  • Event Date Posted
    2008-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73591
  • 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 LZO
  • Reason
    The warning label "do not use with heads more than +10, offset" does not appear on 135 degree stem boxes. this warning is contained in the instructions for use.
  • Action
    Recall notification letters were sent by Fed Ex on August 20, 2008 to Stryker branches/agencies and Hospital Risk Management departments. Letters to Branches stated the reason for the recall and the potential hazard. Both letters state that it is recommended that physicians follow patients in a manner that is consistent with a physicians routine standard of care for total hip arthroplasty. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5000 for assistance.

Device

Device Recall Hipstar V40 Femoral Stem
  • Model / Serial
    Catalog # Lot Code 78501006 G1167520 78501006 G1167521 78501006 G1167521 78501006 G1228787 78501006 G1229912 78501006 G1229912 78501006 G1230461 78501006 G1230461 78501006 G1239108 78501006 G1239108 78501007 G1229913 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501009 G1076126 78501009 G1076126 78501009 G1076126 78501009 G1090547 78501009 G1090547 78501009 G1090547 78501009 G1090547 78501009 G1230631 78501009 G1230631 78501010 G1167526 78501010 G1167526 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1285646 78501010 G1285646 78501011 GC981487 78501011 GC981487 78501011 GC981487 78501011 GC981487 78501011 GC981487 and 78501012 GC966512
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Hipstar V40 Femoral Stem || Howemedica: || Benoist Girard et Cie; 203 bd de la Grande Selle B.P.8; 14201 Herouville Saint Clair. Used in total and hemi hip arthroplasty for: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  • 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