Events

Recall of ArthroCare ArthroWands

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ArthroCare 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
    48731
  • Event Risk Class
    Class 2
  • Event Number
    Z-2309-2008
  • Event Initiated Date
    2008-04-09
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72014
  • 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
    Product is not secure in packaging, and movement may damage the product or render it non-sterile.
  • Action
    Recall initiated April 9, 2008. All consignees were sent a letter of the recalled product on April 9 and May 13, 2008. All non-responding consignees were sent a second letter titled Recall - Covator with Integrated Cable Wand Recall No. 2951580-06/24/08 on June 24, 2008. Contact Bruce Prothro at 408-735-6229 if you have questions.

Device

ArthroCare ArthroWands
  • Model / Serial
    Lot numbers C401580-A, C401770-A, C405180-A, C409550-A, C411570-A, C412350-A, C415070-A, C415970-A, C416150-A, C423570-A, C424960-A, C430270-A, C432770-A, and C434670-A
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 247 consignees throughout the US and to Australia, Germany, Italy, UK, Austria, Netherlands, Switzerland, Denmark, South Africa, Finland, Singapore, Spain, Russia and Poland.
  • Product Description
    ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation accessories. Product is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
  • Manufacturer
    ArthroCare Corporation

Manufacturer

ArthroCare Corporation
  • Manufacturer Address
    ArthroCare Corporation, 680 Vaqueros Ave, Sunnyvale CA 94085-3523
  • Source
    USFDA