Events

Recall of Device Recall Linvatec Power Cord Reel Catalog Number:

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
    56829
  • Event Risk Class
    Class 2
  • Event Number
    Z-0847-2011
  • Event Initiated Date
    2010-02-23
  • Event Date Posted
    2011-01-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94603
  • 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
    Camera, surgical and accessories - Product Code KQM
  • Reason
    Conmed linvatec, endoscopy division, dba. conmed linvatec, largo, florida is recalling five products: (1.) video cart premium 120 vac (vp6501), (2.) video cart multi-specialty 120 vac (vp6502), (3.) video cart articulating arm 120v (vp6504), (4.) video cart (vp8500), and (5.) power cord assembly self retracting (vp6547). these products are being recalled due to there is a possibility that the vid.
  • Action
    ConMed Linvatec sent URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters to their customers by FedEx. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to review their plugs for damage and determine if they were affected. Distributors were asked to contact affected customers and schedule delivery of their replacement plugs within 30 days. If the account no longer has the product in their possession, or if they have transferred the product, they were asked to respond as such via a Reply form. Customers were asked to document delivery of replacement plugs on the Sales Rep Reply Form and mail back or return by fax to 1-888-370-3062. For questions regarding this recall call the Customer Service Department at 1-888-292-0100 or e-mail Custserv1@Invatec.com.

Device

Device Recall Linvatec Power Cord Reel Catalog Number:
  • Model / Serial
    Power Cord Assembly Self Retracting (Catalog Number: VP6547)  Lot Number: 1160 1533 1590 1959 2534 2558 2595 2724 2798 2905 3009 3269 3428 3831 3831 4099 4498 4894 5209
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Canada, Chile, Colombia, Denmark, Korea, Mexico, Singapore, South Africa, United Arab Emirates, and Venezuela.
  • Product Description
    The Power Cord Reel is labeled as follows: || REF, VP6547, QTY1, POWER CORD REEL, Rx ONLY. || These Video Carts are intended for storage of Endoscopic equipment that is used in single or multiple surgical specialties || MANUFACTURED FOR: Linvatec, LINVATEC CORPORATION, LARGO, FL 33773 USA.
  • 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