Recall of Device Recall Guide and KWires for T2 and Gamma Systems

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophil - Product Code MAY
  • Reason
    During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
  • Action
    Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to the instructions provided.


  • Model / Serial
    Catalog number 1806-0090S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Nationwide Distribution
  • Product Description
    Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
  • Manufacturer


  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
  • Source