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-0354-2008
  • 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=64687
  • 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: 203767 203769 203809 203829 203839 203940 203941 203942 203953 203965 203966 203967 203968 204010 204018 204019 204130 204236 204242 204250 204251 204252 204284 204285 204286 204292 204293 204294 204295 204314 204315 204316 204356 204357 204358 204359 204360 204361 204368 204377 204379 204380 204400 204401 204412 204433 204434 204437 204438 204609 204610 204611 204624 204657 204667 204668 and  204669
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Arthrocare 6.5 mm ParaSorb, Preloaded with 2 || MagnumWire sutures (1 white/1 co-braid), Part Number: 22-5065, 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