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
    64456
  • Event Risk Class
    Class 2
  • Event Number
    Z-0964-2013
  • Event Initiated Date
    2013-01-24
  • Event Date Posted
    2013-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116175
  • 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
    orthopedic manual surgical instrument - Product Code LXH
  • Reason
    The standard triathlon femoral stylus does not fit into the specialty sizers and the "r" and "l" markings on the right sizer are reversed.
  • Action
    A Notification Letter/Product Accountability Form dated 01/28/2013 was sent via FedEx on 01/28/2013 to the sole US branch receiving the affected devices. The branch was instructed to also contact the hospitals in its territory that have the affected product to arrange return of the product. Affected products to be returned to Stryker Orthopaedics, 325 Corporate Drive, Mahway, NJ 07430.

Device

Device Recall Triathlon
  • Model / Serial
    Catalog Number: I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right).   Lot Codes: AP5W52 and AP7H19.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    1 Branch (NJ) with one consignee (DE).
  • Product Description
    Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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