Events

Recall of Sonotrode Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Richard Wolf Medical Instrument Corp.

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
    27489
  • Event Risk Class
    Class 2
  • Event Number
    Z-0081-04
  • Event Initiated Date
    2003-10-09
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29952
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code FFK--
  • Reason
    The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
  • Action
    Recalled from the hospitals by sales representative telephone calls on 10/9/03 and follow-up visits to retriev the recalled lot and replace the units with a new lot of sonotrodes.

Device

Sonotrode Probe
  • Model / Serial
    Model 8963.535, lot number M000580
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nebraska, Oregon, Minnesota and Illinois.
  • Product Description
    Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory to the Richard Wolf Model 2271 Ultrasound Generator Unit 2271; Richard Wolf Medical Instruments Corp., Vernon Hills, IL 60061
  • Manufacturer
    Richard Wolf Medical Instrument Corp

Manufacturer

Richard Wolf Medical Instrument Corp
  • Manufacturer Address
    Richard Wolf Medical Instrument Corp, 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • Source
    USFDA