Events

Recall of Device Recall Coblator II System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ArthroCare Medical Corporation.

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
    70594
  • Event Risk Class
    Class 2
  • Event Number
    Z-1323-2015
  • Event Initiated Date
    2015-02-20
  • Event Date Posted
    2015-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134100
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    The recalling firm was notified by the contract manufacturer that they had reversed the l2, l3, l4, or l5 components on the p/n09010 rohs boards of the coblator ii controller (model rf8000e).
  • Action
    ArthroCare sent an Urgent Medical Device Recall letter dated February 2015 to customers. A response form will be included in the letter and a follow up notifcation letter will be sent to non-responding consignees. The letter identified the affected product, problem and actions to be taken. For questions contact your local Returns Department Representative at 800-343-5717, option 3.

Device

Device Recall Coblator II System
  • Model / Serial
    Serial Numbers: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, CA0N0000GH
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.
  • Product Description
    Coblator II System, 120V. || Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
  • Manufacturer
    ArthroCare Medical Corporation

Manufacturer

ArthroCare Medical Corporation
  • Manufacturer Address
    ArthroCare Medical Corporation, 7000 W William Cannon Dr, Austin TX 78735-8509
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA