Events

Recall of Device Recall Medtronic Xomed

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

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
    28980
  • Event Risk Class
    Class 3
  • Event Number
    Z-0953-04
  • Event Initiated Date
    2004-01-29
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32906
  • 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
    Bur, Surgical, General & Plastic Surgery - Product Code GFF
  • Reason
    The curve in the shaft of the bur was only 15 degrees not the labeled 40 degrees.
  • Action
    A Recall notification letter was mailed to each hospital account on January 29, 2004 for each type of device they received which was under recall explaining the error and asking the accounts to remove recalled product from inventory, fax them the response sheet and to return the products.

Device

Device Recall Medtronic Xomed
  • Model / Serial
    Lot 26371200
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Products were distributed to 23 hospitals and surgical centers in NC, NB, IN, UT, TX, NY, WI, MO, TN, ID, OK, FL, MA, WY, NJ, LA.
  • Product Description
    Product is a surgical nasal/sinus surgical device labeled as a RAD Frontal Finesse Bur, Reference Number 18-83070
  • Manufacturer
    Medtronic Xomed, Inc.

Manufacturer

Medtronic Xomed, Inc.
  • Manufacturer Address
    Medtronic Xomed, Inc., 6743 Southpoint Dr N, Jacksonville FL 32216-6218
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA