Events

Recall of Device Recall Stryker Howmedica Osteonics Corp.

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
    63442
  • Event Risk Class
    Class 2
  • Event Number
    Z-0470-2013
  • Event Initiated Date
    2012-07-27
  • Event Date Posted
    2012-12-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114071
  • 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
    Offset bushings associated with the lots identified were mismarked: the rotational reference numbers on the tibial offset bushing were marked counterclockwise instead of clockwise; the femoral offset bushing did not include rotational markings.
  • Action
    Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated July 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgement Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for assistance with this recall.

Device

Device Recall Stryker Howmedica Osteonics Corp.
  • Model / Serial
    Class I, 510(k) exempt  Catalog Number: 6543-2-600  Lot Number: P1S43, P2A31
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Stryker Orthopaedics || TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS || REF 6543-2-600;NON-STERILE || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || A Subsidiary of Stryker Corp. || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green 69881 Meyzieu || Cedex France || Made in USA || The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.
  • 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