Events

Recall of Device Recall APEX Arthroscopy Tubing Set

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
    65320
  • Event Risk Class
    Class 2
  • Event Number
    Z-1681-2013
  • Event Initiated Date
    2013-05-30
  • Event Date Posted
    2013-07-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118564
  • 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
    Arthroscope - Product Code HRX
  • Reason
    Conmed linvatec received complaints that their products c7120 apex arthroscopy tubing set, one connection and c7122 apex arthroscopy tubing set, two connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the apex irrigation (pump) console to sense a pressure drop and increase fluid flow to the surgical site.
  • Action
    ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery or equivalent on 5/30/2013 to all domestic direct consignees. ConMed Linvatec is translating customer notifications letters into the necessary languages and will send International notification letters no later than 6/4/2013.

Device

Device Recall APEX Arthroscopy Tubing Set
  • Model / Serial
    C7122 Lots #'s: 1301224, 1301234, 1301244, 1301304, 1301314, 1302114, 1302154, 1302274, 1302284, 1303144, 1303254, 1304044, 1304234, 1304244, and 1305024
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan.
  • Product Description
    ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. || Intended for use for joint irrigation and dissention during arthroscopic procedures.
  • 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