Events

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-0352-2008
  • Event Date Posted
    2007-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64684
  • 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

Arthrocare, ParaSorb
  • Model / Serial
    Lot Numbers:  203766 203768 203788 203857 203858 203859 203879 203884 203885 203918 203919 203925 203931 203932 203969 204009 204129 204174 204185 204186 204218 204219 204224 204234 204235 204240 204241 204257 204258 204259 204267 204268 204269 204274 204275 204276 204296 204311 204312 204313 204324 204325 204326 204327 204328 204329 204382 204429 204456 204457 204597 204598 204606 204615 204616 204617 204618 204699 204700 204701 and  204702
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Arthrocare 5.5mm ParaSorb, pre-loaded with 2 || MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5055 , Axya Medical, Inc., Beverly, MA 01915
  • Manufacturer
    Axya Medical

Manufacturer

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