Events

Recall of Howmedica

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

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
    26996
  • Event Risk Class
    Class 3
  • Event Number
    Z-1295-03
  • Event Initiated Date
    2003-08-04
  • Event Date Posted
    2003-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28969
  • 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
    Rod, Fixation, Intramedullary And Accessories - Product Code HSB
  • Reason
    The device does not have an oblong hole for dynamic locking as required.
  • Action
    Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt.

Device

Howmedica
  • Model / Serial
    Lot K884459
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    The 6 units were distributed to Howmedica Branch and sales agents located in PA, VA, GA, KS, and CA.
  • Product Description
    T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
  • Manufacturer
    Stryker Howmedica Osteonics

Manufacturer

Stryker Howmedica Osteonics
  • Manufacturer Address
    Stryker Howmedica Osteonics, 300 Commerce Court, Mahwah NJ 07430
  • Source
    USFDA