Events

Recall of Device Recall Tumark Q

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Somatex Medical Technologies 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
    78349
  • Event Risk Class
    Class 2
  • Event Number
    Z-0410-2018
  • Event Initiated Date
    2017-05-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159289
  • 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
    Marker, radiographic, implantable - Product Code NEU
  • Reason
    There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
  • Action
    On May 22, 2017, Somatex Medical Technologies distributed notices to their customers advising them of the reason for recall. Customers are advised to inspect stock, quarantine and not use affected product. Products will be exchanged free of charge and a replacement delivery will be arranged promptly. All customers are expected to complete and return the response form via fax.

Device

Device Recall Tumark Q

Manufacturer

Somatex Medical Technologies GmbH
  • Manufacturer Address
    Somatex Medical Technologies GmbH, Rheinstr. 7 d, Teltow Germany
  • Manufacturer Parent Company (2017)
    E-Med Solutions Gmbh
  • Source
    USFDA