Events

Recall of Device Recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable

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
    71468
  • Event Risk Class
    Class 2
  • Event Number
    Z-2105-2015
  • Event Initiated Date
    2015-06-02
  • Event Date Posted
    2015-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137892
  • 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
    Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (hipot) specifications.
  • Action
    Smith&Nephew; sent an Urgent Notification letter dated June 10, 2015 via mail/courier service with delivery tracking/confirmation to affected customers. A response form is included in the notification letter. A follow up letter will be sent to non-responding consignees. Customers were instructed to complete the acknowledgement form and return via fax or email.

Device

Device Recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable
  • Model / Serial
    Lot numbers 1093290 and 1091254
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Australia, Belgium, Germany, Spain, United Kingdom, Ireland, India, Italy and Singapore.
  • Product Description
    EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable || Product Usage: || PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
  • 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