Events

Recall of Device Recall Stryker Vitallium Wire (6 Pack) Non Sterile

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
    73042
  • Event Risk Class
    Class 2
  • Event Number
    Z-0855-2016
  • Event Initiated Date
    2015-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142877
  • 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
    Staple, fixation, bone - Product Code JDR
  • Reason
    The wire packages are correctly marked with a "non-sterile" label, however, the enclosed instructions for use (ifu) states the device are sterilized via gamma irradiation and should not be resterilized. since the ifu states the devices are sterile, no instructions for moist heat sterilization are provided.
  • Action
    Stryker Branches/Agents were notified of the action via email on December 23, 2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated December 23, 2015 were sent to Branches/Agents via UPS on December 28, 2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated December 23, 2015 were sent to Hospital Risk Managers and doctors via UPS on 12/23/2015. The notification instructed customers of the related issue with the affected product; how to identify affected product; the potential hazards associated with affected product; risk mitigations; and actions needed to be taken. Customers were asked to complete and return the attached Product Recall Acknowledgement Form within 5 days and either email (strykerOrtho7808@stericycle.com or Fax (1-866-672-0627 ) the response form back. Customers were instructed to return all affected products to Stryker C/O Stericycle, 2670 Executive Drive, Suite A, Indianapolis, IN 46241 (Attn RA2015-120-Event 7808). A point of contact was provided in case the customer had any questions 201.831.5272 .

Device

Device Recall Stryker Vitallium Wire (6 Pack) Non Sterile
  • Model / Serial
    All lots of the following Catalog Numbers: 2704-1-024; 2704-3-018; 6703-1-018; 6703-2-120; 6704-1-018; 6704-2-120 and 6704-3-120.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
  • 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