Events

Recall of Total Knee Joint Replacement Prosthesis

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
    49573
  • Event Risk Class
    Class 2
  • Event Number
    Z-0579-2009
  • Event Initiated Date
    2006-09-21
  • Event Date Posted
    2009-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73830
  • 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 joint - Product Code MBH
  • Reason
    Stryker orthopaedics became aware that one lot of the triathlon primary beaded pa baseplate size 5 may not have the peri-apatite coating.
  • Action
    Important Market Withdrawal notification letters were sent via Fed Ex on 9/20/06 to the direct accounts. Notification letters informed of the reason for the market withdrawal and requested that all branches examine their inventory and hospital consignment locations to identify the product. Product was to be reconciled on the Product Accountability Form and returned to Stryker as per instructions. Contact Stryker Howmedica Osteonics Corp at 1-201-831-5718 for assistance.

Device

Total Knee Joint Replacement Prosthesis
  • Model / Serial
    Lot Code SANMH
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    PA, GA, AL, WI, UT, and OR.
  • Product Description
    Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded wPA; Catalog Number 5526-B-500, Cementless use only. Sterile. || Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corp. Made in Ireland. || The Triathlon Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function.
  • 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