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U.S. Department of Health and Human Services

Class 2 Device Recall Sonotrode Probe

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  Class 2 Device Recall Sonotrode Probe see related information
Date Initiated by Firm October 09, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 10, 2004
Recall Number Z-0081-04
Recall Event ID 27489
510(K)Number K011065  
Product Classification unknown device name - Product Code FFK--
Product 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
Code Information Model 8963.535, lot number M000580
Recalling Firm/
Richard Wolf Medical Instrument Corp
353 Corporate Woods Pkwy
Vernon Hills IL 60061-3110
For Additional Information Contact Mr. Robert L. Casarsa
Manufacturer Reason
for Recall
The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
FDA Determined
Cause 2
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.
Quantity in Commerce 10 probes
Distribution Nebraska, Oregon, Minnesota and Illinois.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FFK-- and Original Applicant = RICHARD WOLF MEDICAL INSTRUMENTS CORP.