Events

Recall of Device Recall ArthroKnife

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
    52808
  • Event Risk Class
    Class 2
  • Event Number
    Z-0067-2010
  • Event Initiated Date
    2009-07-31
  • Event Date Posted
    2009-10-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84047
  • 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
    Knife, orthopedic - Product Code HST
  • Reason
    Conmed has determined there is a possibility that the device may not fully retract once it is deployed.
  • Action
    ConvaMed Linvatec USA issued an "Urgent Medical Device Recall" notification via Fed Ex to all direct consignees of the affected product. Users were asked to inventory and return all affected product to the firm and to return a reply form by mail or fax. For further information, contact customer service at 1-800-237-0169 for US or your local ConMed Linvatec office for outside US or email at Custserv1@linvatec.com.

Device

Device Recall ArthroKnife
  • Model / Serial
    All product with the following Catalog Numbers:  70-0071-103 ANTHRO-KNIFE BANANA STR 6EA;  70-0078-103 ARTHRO-KNIFE 2 SIDE RND S 6 EA;  70-0071-113 ARTHRO-KNIFE BANANA LEFT 6 EA;  70-0074-103 ARTHRO KNIFE ROSETTE STR 6 EA;  70-0076-003 ARTHRO KNIFE CRESENT STR 6 EA;  70-0077-103 ARTHRO-KNIFE 2-SIDE POINT 6 EA;  70-0072-003 ARTHRO-KNIFE HOOK STR 6 EA;  70-0073-003 ARTHRO-KNIFE RETRO STR 6 EA;  70-0075-003 ARTHRO-KNIFE MINI MENISCU 6 EA.
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.141.517. || The Arthro-Knife is a one piece disposable assembly comprised of a plastic handle with a retractable blade, sheathed blade. These knives are supplied sterile, single-use. Each knife assembly contains a color coded sliding retractor that coincides with a specific blade type. The blade can be extended and locked to a half extended position or fully extended position.
  • 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