Events

Recall of Device Recall Trident

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
    52289
  • Event Risk Class
    Class 2
  • Event Number
    Z-1703-2009
  • Event Initiated Date
    2009-06-09
  • Event Date Posted
    2009-08-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82672
  • 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 prosthesis surgical procedure - Product Code MRA
  • Reason
    The surgical protocol has been modified to create separate and distinct surgical protocols, one for the trident¿ psl shell (lsp68) and one for the trident¿ hemispherical shell (lsp69) in order to clarify and highlight the differences in reaming technique.
  • Action
    Stryker sent Urgent - Product Correction - Surgical Protocol letters by Federal Express on June 9, 2009 to all Stryker branches/agencies, hospital Risk Management, hospital Chief of Orthopaedics, surgeons and all foreign consignees.

Device

Device Recall Trident
  • Model / Serial
    Literature Number LSP55, all units, no lot number.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution.
  • Product Description
    Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.
  • 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