Events

Recall of Device Recall Triathlon X3 Posterior Stabilized Tibial Insert

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
    50738
  • Event Risk Class
    Class 2
  • Event Number
    Z-1013-2009
  • Event Initiated Date
    2008-12-18
  • Event Date Posted
    2009-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76807
  • 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 Components - Product Code JWH
  • Reason
    Stryker orthopaedics became aware of a lot for lot mix-up between part numbers 5532-g-713, lot code lbd528 (triathlon x3 posterior stabilized tibial insert, size 7-13 mm) and part 5532-g-813, lot code lbd512 (triathlon x3 posterior stabilized tibial insert size 8-13 mm).
  • Action
    Urgent Product Recall letters were sent via Federal Express on December 18, 2008 with return receipt to Stryker branches, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation factors. The firm asked customers to examine their inventory and hospital locations to identify affected product; retrieve all affected product and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form; and return affected product. Questions should be directed to Karen Ariemma at 201-831-5718.

Device

Device Recall Triathlon X3 Posterior Stabilized Tibial Insert
  • Model / Serial
    Lot code LBD528 and Lot code LBD512.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution: FL and IL.
  • Product Description
    Triathlon X3 Posterior Stabilized Tibial Insert || Use with Triathlon PS Femoral Components. || Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; || Catalog number 5532-G-713, Catalog number 5532-G-813 || Stryker Orthopaedics
  • 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