Class 2 Device Recall Sonotrode Probe

• Date Initiated by Firm: October 09, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated 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: 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--