Events

Recall of Stryker Flat Panel Arm

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
    55498
  • Event Risk Class
    Class 2
  • Event Number
    Z-1605-2010
  • Event Initiated Date
    2010-04-07
  • Event Date Posted
    2010-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90996
  • 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
    Anesthetic cabinet, table, or tray - Product Code BRY
  • Reason
    Some of the pitch shafts were not properly welded which results in the monitor becoming unlevel.
  • Action
    An Urgent: Medical Device Recall letter dated April 19, 2010 was sent to customers. It was recommended that customers continue use of the product unless the monitor becomes unlevel. The customer was notified that a Stryker Representative would contact their facility to coordinate a service call to inspect the affected units. Questions are directed to the firm via phone at 972-410-7617 or via email at .

Device

Stryker Flat Panel Arm
  • Model / Serial
    Catalog number: 0682400028 Lot numbers 1003, 1004, 1005, 1006. Serial numbers from 00001-01529
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide --US and Canada, Australia, China (Hong Kong), Latin America (Mexico, Chile, Ecuador, Costa Rica) .
  • Product Description
    Universal Flat Panel Yoke, a component of the Stryker Flat Panel Arm. The yoke is intended to hold a flat panel monitor.
  • 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