Events

Recall of SONNET

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by MED-EL Elektromedizinische Gereate, Gmbh.

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
    76503
  • Event Risk Class
    Class 2
  • Event Number
    Z-1395-2017
  • Event Initiated Date
    2016-10-25
  • Event Date Posted
    2017-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153386
  • 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
    Pylon, post surgical - Product Code ISM
  • Reason
    Unit defect: firm inspection revealed units did not have the compartment lock firmly welded to the housing.
  • Action
    MED-EL is notifying all consignees to whom affected products have been directly shipped by Headquarters (based on first delivery shipment records) on 10/25/2016.

Device

SONNET
  • Model / Serial
    Part No. 32291, Kit 33372, Kit UDI - Primary ID: 09008737333720 (anthracite 50); Part No. 32292, Kit 33374, Kit UDI - Primary ID: 09008737333744 (ebony 50); Part No. 32293, Kit 33375, Kit UDI - Primary ID: 09008737333751 (black 50); Part No. 32294, Kit 33376, Kit UDI - Primary ID: 09008737333768 (white 50); Part No. 32295, Kit 33377, Kit UDI - Primary ID: 09008737333775 (beige 50) and Part No. 32296, Kit 33378, Kit UDI - Primary ID: 09008737333782 (grey 50).
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.
  • Product Description
    SONNET Mini Battery Pack CableProduct Usage: || The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.
  • Manufacturer
    MED-EL Elektromedizinische Gereate, Gmbh

Manufacturer

MED-EL Elektromedizinische Gereate, Gmbh