Recall of Arthrocare, ParaSorb

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

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
    44963
  • Event Risk Class
    Class 2
  • Event Number
    Z-0351-2008
  • Event Date Posted
    2007-12-08
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2012-06-21
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Sutures - Product Code MBI
  • Reason
    Sterility compromised (package integrity): sterility of the device may be compromised due to holes in the sterile packaging.
  • Action
    Axya Medical notified customers by letter, Urgent-Product Recall, dated 9/25/07 , via UPS . Users are requested to return product and complete the reply form.

Device

  • Model / Serial
    Lot Numbers:  204007 204008 204016 204017 204045 204057 204058 204069 204072 204530 204531 204532 204548 204563 204564 204570 204571 and 204588
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Arthrocare 3.0mm ParaSorb, Preloaded with 2 || MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5030, Axya Medical, Inc., Beverly, MA 01915
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Axya Medical, 100 Cummings Ctr Ste 444c, Beverly MA 01915-6132
  • Source
    USFDA