Events

Recall of Device Recall STIC

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

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
    32842
  • Event Risk Class
    Class 2
  • Event Number
    Z-0034-06
  • Event Initiated Date
    2005-07-22
  • Event Date Posted
    2005-10-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40929
  • 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
    Monitor, Pressure, Intracompartmental - Product Code LXC
  • Reason
    The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
  • Action
    Consignees were notified by recall letter dated August 5, 2005 to locate the affected serial numbers and to return the product to the firm.

Device

Device Recall STIC
  • Model / Serial
    Serial numbers 0428702183 through 0518008193.
  • Product Classification
    Orthopedic Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Australia, Canada, Costa Rica, England, France, Germany, Hong Kong, India, Indonesia, Japan, Netherlands, New Zealand, South Africa, Spain, Sweden, Switzerland, Taipei, Turkey and United Arab Emir.
  • Product Description
    Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham, Kalamazoo MI 49001
  • Source
    USFDA