Events

Recall of Cavity SpineWand

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
    72789
  • Event Risk Class
    Class 2
  • Event Number
    Z-0623-2016
  • Event Initiated Date
    2015-10-26
  • Event Date Posted
    2016-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142214
  • 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
    There is cracking in the tray when the device is snapped into place. the crack is through the full thickness of the tray, compromising the sterile barrier.
  • Action
    Affected consignees will be notified via letter beginning 11/2/15.

Device

Cavity SpineWand
  • Model / Serial
    Lot Numbers: 1024313, 1024482, 1027160, 1034306, 1041879, 1059328
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including OH, MO, AZ, AL, CA, FL, SC, GA, and PA; Spain, France, United Kingdom, Germany, Switzerland, Singapore, Russia, Turkey, and Ecuador.
  • Product Description
    Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.
  • Manufacturer
    ArthroCare Corporation

Manufacturer

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