Events

Recall of Device Recall Stem Trial, Triathlon Revision Instruments

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
    48596
  • Event Risk Class
    Class 2
  • Event Number
    Z-2157-2008
  • Event Initiated Date
    2008-05-14
  • Event Date Posted
    2008-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71695
  • 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
    Template - Product Code HWT
  • Reason
    Triathlon ts stems trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.
  • Action
    Urgent Product Recall notification letters were sent to all Stryker Branch/Agency Manager/Quality contacts on May 14, 2008 via Federal Express. The letter requests that consignees examine their inventory and hospital consignment locations to identify the product; and retrieve all affected product lots and return it to their branch or agency warehouse for reconciliation. The letter also states that a Stryker Orthopaedics Customer Service rep should be contacted for alternative products available.

Device

Device Recall Stem Trial, Triathlon Revision Instruments
  • Model / Serial
    All lot codes
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Australia, Canada, Sweden, Germany, Spain, Portugal, United Kingdom.
  • Product Description
    Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length || Catalog numbers: || 5565-T-009, 5565-T-010, 5565-T-011, 5565-T-012, 5565-T-013, 5565-T-014 || 5565-T-015, 5565-T-016, 5565-T-017, 5565-T-018, 5565-T-019, 5565-T-020 || 5565-T-021, 5565-T-022, 5565-T-023, 5565-T-024, 5565-T-025 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 || Used in Revision TKA.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA