Events

Recall of Device Recall Triathlon

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
    37024
  • Event Risk Class
    Class 2
  • Event Number
    Z-0399-2007
  • Event Initiated Date
    2006-12-04
  • Event Date Posted
    2007-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49780
  • 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
    knee prosthesis component - Product Code JWH
  • Reason
    A product mix-up in which the labeling indicates a triathlon x# cr tibial bearing insert size #2 - 11mm, however, the device inside the package is actually a triathlon x3 cr tibial bearing insert size # 7 - 11mm and vice versa.
  • Action
    Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.

Device

Device Recall Triathlon
  • Model / Serial
    Ref. No. 5530-G-211 Lot code G9XF6  LAF974
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Canada.
  • Product Description
    Triathlon X3 CR Tibial Bearing Insert || for knee prosthesis || Size #2 - 11MM || Ref # 5530-G-211 || 2011-09 || Howmedica Osteonics Corp.
  • 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