Events

Recall of Device Recall Omnifit EON Surgical Protocol

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
    47764
  • Event Risk Class
    Class 2
  • Event Number
    Z-1750-2008
  • Event Initiated Date
    2007-05-17
  • Event Date Posted
    2008-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70091
  • 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 Protocol - Product Code LXH
  • Reason
    The table 2 broach and neck trial sizing (literature # lsp48 04/04) on page 3 is incorrect, reading 5mm less than what it should be for certain sizes.
  • Action
    Styrker Branches/Agencies were notified of the incorrect information printed in the protocal on May 17, 2007 via an Important Product Correction letter. The letter requested that all incorrect copies of the protocol be located and destroyed immediately. They requested that the Acknowledgement Form be completed and faxed, and that a Stryker Orthopaedics Customer Service rep be contacted in order to reorder the destroyed product.

Device

Device Recall Omnifit EON Surgical Protocol
  • Model / Serial
    Literatur Number LSP48 4/04
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, Australia, Latin America and Greece.
  • Product Description
    Omnifit EON Surgical Protocol; || Literature Number: LSP48 4/04 || Stryker Howmedica Osteonics Corp., Mahwah, NJ
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA