Events

Recall of Device Recall Trident Acetabular Hip System

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
    50150
  • Event Risk Class
    Class 2
  • Event Number
    Z-0909-2010
  • Event Initiated Date
    2006-02-17
  • Event Date Posted
    2010-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74832
  • 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
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Reason
    Stryker orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of x# polyethylene used on scorpio, triathlon and trident inserts.
  • Action
    Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825.

Device

Device Recall Trident Acetabular Hip System
  • Model / Serial
    Lot Numbers: 36481101; 36491201; 36514901; 36609101; 36517801; 36526201; 36602201; 36422401; 36631201; 36643801; 36425501; 36448901; 36647201; 36737701; 36742301; 36772901; 36775301; 36547101; 36563001; 36473901; 36738101; 36609001; 36466401; 36642601; 36481401 and 36428401.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States and Canada.
  • Product Description
    Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ. || Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and restore function in the hip.
  • 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