Events

Recall of Device Recall Universal Titanium Prosthesis,

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
    66355
  • Event Risk Class
    Class 2
  • Event Number
    Z-2284-2013
  • Event Initiated Date
    2013-08-23
  • Event Date Posted
    2013-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122139
  • 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
    Total & partial middle ear prostheses, ossicular - Product Code ETA
  • Reason
    One lot of the product was assembled using the cam head version of the same prosthesis instead of the round head shaft.
  • Action
    An "URGENT PRODUCT RECALL" letter was faxed to customers following the initial telephone notification. The letter described the product issue and provided recommended actions. Questions were directed to customer service at 800-874-5797.

Device

Device Recall Universal Titanium Prosthesis,
  • Model / Serial
    REF: 1150000 Lot: 0207029284
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
  • Product Description
    Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
  • 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