Events

Recall of Device Recall Stryker Orthopaedics Triathlon X3 Tibial Bearing 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
    71678
  • Event Risk Class
    Class 2
  • Event Number
    Z-2389-2015
  • Event Initiated Date
    2015-05-29
  • Event Date Posted
    2015-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138725
  • 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, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
  • Reason
    Stryker has received a report which identified that a triathlon tibial bearing insert cs x3 size #2 9mm (5531-g-209) was reported to be in a pack that was labelled as a cr insert (5530-g-209).
  • Action
    Stryker Orthopaedics sent a recall notification via email on 5/29/2015 to their local branches. Notification letters and Product Accountability Forms were sent to Stryker branches/agencies with return receipts on 7/2/2015.

Device

Device Recall Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert
  • Model / Serial
    Catalog number 5530-G-209   Lot Code LEF064
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    OH, SC, RI, WV
  • Product Description
    Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR || REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA