Events

Recall of Device Recall V 40 Femoral Head

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
    52525
  • Event Risk Class
    Class 2
  • Event Number
    Z-1822-2009
  • Event Initiated Date
    2009-06-18
  • Event Date Posted
    2009-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83194
  • 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
    Hip Semi-Constrained Metal/Polymer Uncemented Prosthesis - Product Code LWJ
  • Reason
    Sterilization issue: during post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.
  • Action
    Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.

Device

Device Recall V 40 Femoral Head
  • Model / Serial
    lot # 29213701;Exp. 1/28/2014 and lot # 29228301; Exp 1/28/2014
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., || Stryker Ireland, Carrigtwohill County Cork, Ireland; || Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
  • 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