Events

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
    Recall
  • Event ID
    73156
  • Event Risk Class
    Class 2
  • Event Number
    Z-0873-2016
  • Event Initiated Date
    2016-01-21
  • Event Date Posted
    2016-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143495
  • 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 Stericycle.by the instructions provided.

Device

Device Recall Guide and KWires for T2 and Gamma Systems
  • Model / Serial
    Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Stryker, T2 K-Wire, 3x285 mm || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
  • 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