Events

Recall of Device Recall Surgical Table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Communications 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
    48197
  • Event Risk Class
    Class 2
  • Event Number
    Z-2189-2008
  • Event Initiated Date
    2008-05-01
  • Event Date Posted
    2008-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70986
  • 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
    Table, Operating-Room, Ac-powered - Product Code FQO
  • Reason
    Potential exists for energy chain, which is responsible for protecting hydraulic and electrical cables during up and down motion on vertier surgical table, to become lodged between column case sections resulting in possible reduction or lose of function to hand and/or foot controls or possible involuntary movement of the table.
  • Action
    Firm notified consignees via letter titled URGENT: Device Recall, dated 04/01/08. Consignees notified of issue and were told a company representative would visit the firm to perform the required maintenance. Contact Karen Smith-Mosley at 972-410-7310 if you have questions.

Device

Device Recall Surgical Table
  • Model / Serial
    Lot/Serial #:070119-24045; 070119-24043; 070202-25062; 070319-27231; 070319-27232; 070202-25058; 071026-39230; 071026-39232; 070216-25279; and 071019-38649.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to the following states: CA, CO, TX and UT.
  • Product Description
    Surgical Table Column Casing Revision B, Product #0788-200-001 Revision B; component of Stryker's VERTIER Surgical Table distributed by Stryker Communications, Flower Mound, TX 75028. The tables are AC-powered or air-powered devices intended for use during diagnostic examination or surgical procedures to support the patient.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

Stryker Communications Corp
  • Manufacturer Address
    Stryker Communications Corp, 1410 Lakeside Pkwy Ste 100, Flower Mound TX 75028-4026
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA