Events

Recall of T2 System, Condyle Screw

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
    33895
  • Event Risk Class
    Class 2
  • Event Number
    Z-0169-06
  • Event Initiated Date
    2005-10-04
  • Event Date Posted
    2005-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42708
  • 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
    Screw, Fixation, Bone - Product Code HWC
  • Reason
    Stryker orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced g/k, t2 condyle and some s2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
  • Action
    The product recall will extend to all branches.agencies and hospitals that have received the product.

Device

T2 System, Condyle Screw

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