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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/
Manufacturer		 Richard Wolf Medical Instrument Corp
353 Corporate Woods Pkwy
Vernon Hills IL 60061-3110
For Additional Information Contact Mr. Robert L. Casarsa
800-323-9653
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		 Other
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.
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