Events

Recall of Articulating Arm, Secondary Flat Panel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Linvatec Corp. dba ConMed Linvatec.

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
    58009
  • Event Risk Class
    Class 2
  • Event Number
    Z-1893-2011
  • Event Initiated Date
    2010-09-17
  • Event Date Posted
    2011-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97963
  • 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
    Surgical Camera and Accessories - Product Code KQM
  • Reason
    If the vhm arm is left in the locked position, the gas spring can lose pressure and releasing the lock can result in a sudden downward movement.
  • Action
    An Urgent Service Bulletin Notification was mailed to each ConMed Linvatec customer who received the affected product. The letter identified the affected product and stated the reason for notification. The letter asks customers to review the GCX Corporation Service Bulletins and updated Installation/User Manual. ConMed Linvatec recommends that customers periodically check the VHM Arm to see that it is functioning properly. In addition "Sudden Movement" stickers, provided by GCX, were also included to all consignees as part of the mailing. If customers in the US have questions or need technical support, they can contact ConMed Linvatec Endoscopy Customer Service at 888-292-0100 or e-mail Customerserv1@linvatec.com.

Device

Articulating Arm, Secondary Flat Panel
  • Model / Serial
    Serial Numbers: 0409 080422004 081117004 1056 1268 1314 1505 1539 1588 1661 178 1828 1896 2082 2289 2424 2543 2651 2752 2993 3343 3423 3424 3486 3507 3531 3588 3600 3611 366 3671 3701 3831 424 4269 461 6054 615 6238 652 735 787 847 887 955, and  989.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Australia, Canada, Morocco, Saudi Arabia, Taiwan, Province of China, and throughout the U.S.
  • Product Description
    ***REF VP6528***Qty 1***Articulating Arm, Secondary Flat Panel***RX Only***See Instructions for Use***CONMED LINVATEC, CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA*** || Catalog No Product || VPN6528 Articulating Arm, Secondary Flat Panel. || 690-0024-00 Arm, Wall Mount, Flat Screen, GCX || For mounting and positioning of flat screen monitors.
  • Manufacturer
    Linvatec Corp. dba ConMed Linvatec

Manufacturer

Linvatec Corp. dba ConMed Linvatec
  • Manufacturer Address
    Linvatec Corp. dba ConMed Linvatec, 11311 Concept Blvd, Largo FL 33773-4908
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA