Events

Recall of Circlip

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
    49514
  • Event Risk Class
    Class 2
  • Event Number
    Z-0182-2009
  • Event Initiated Date
    2008-09-05
  • Event Date Posted
    2008-10-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73708
  • 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
    Ceiling-mounted device - Product Code FQO
  • Reason
    Circlip component used to suspend flat panel and navigation arm system may become dislodged.
  • Action
    Notification letter was sent to consignees September 5, 2008. Field service will be performed at all affected sites. Old Circlips will be replaced with new clamps that do not allow the arm to fall. Contact Stryker Communications Corp. at 1-972-410-7310 for assistance.

Device

Circlip
  • Model / Serial
    Part numbers: 0682-000-005 (A-O), 0682-000-200, 0682-000-270, 0682-000-280, 0682-000-281, 0682-000-850, and 0682-000-851. All units distributed between December 23, 2003 and September 30, 2006.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and International Distribution
  • Product Description
    Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker Flat Panel and Navigation Arm System are intended for use as a ceiling-mounted device to support a medical grade flat panel monitor or camera in the patient area. The Circlip within the flat panel and navigation arms is part of the mechanical stop designed to prevent the arm from rotating infinitely. It also prevents the cables routed through the arm from becoming twisted during routine movement and rotation of the arm.
  • Manufacturer
    Stryker Communications Corp

Manufacturer

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