Events

Recall of Total Ossicular Replacement Prosthesis, CliP Piston MVP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heinz Kurz GmbH Medizintechnik.

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
    58809
  • Event Risk Class
    Class 2
  • Event Number
    Z-2711-2011
  • Event Initiated Date
    2011-04-27
  • Event Date Posted
    2011-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100338
  • 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
    Replacement, ossicular prosthesis, total - Product Code ETA
  • Reason
    Outer package labels product .75 mm longer than actual size.
  • Action
    Kurz Medical, Inc. sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter dated May 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to return unused product for replacement by using an enclosed FedEx label. If the product has been implanted , the letter requests the customers send the date of surgery and size of the implant.

Device

Total Ossicular Replacement Prosthesis, CliP Piston MVP
  • Model / Serial
    Lot 2 09 13 06
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution--USA (nationwide) including the states of MN, NC, and WA.
  • Product Description
    Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13 06. || Product is designed for ossicular replacement to functionally restore the middle ear in cases of pathologic changes of the conductive hearing mechanism.
  • Manufacturer
    Heinz Kurz GmbH Medizintechnik

Manufacturer

Heinz Kurz GmbH Medizintechnik
  • Manufacturer Address
    Heinz Kurz GmbH Medizintechnik, Tuebinger Strasse 3, Dillingen Germany
  • Manufacturer Parent Company (2017)
    Heinz Kurz GmbH
  • Source
    USFDA