Events

Recall of Device Recall Stryker Orthopaedics

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
    67234
  • Event Risk Class
    Class 2
  • Event Number
    Z-0964-2014
  • Event Initiated Date
    2013-11-20
  • Event Date Posted
    2014-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125053
  • 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
    Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
  • Action
    Stryker Orthopaedics sent notification letters and acknowledgement forms via Fed Ex as follows: Branches-11/20/2013 Hospital Risk Manager - 11/21/2013

Device

Device Recall Stryker Orthopaedics
  • Model / Serial
    Catalog no. 2124-1400 All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    IL MA, MN, ND, OR, & PA
  • Product Description
    Stryker Orthopaedics Navigation Compatible Accolade Broach Handle || 1 single unit to a package || Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA || Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France || Made in USA || non-sterile
  • 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