Z-0081-04

Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory...

Name: Z-0081-04 Sonotrode Probe, a straight nephroscopy probe with a 3.5 mm diameter and 362 mm working length; an accessory...
Creator: Richard Wolf Medical Instrument Corp
Published: 2003-10-09
License: https://open.fda.gov/license/

Richard Wolf Medical Instruments Corp. / initiated 2003-10-09 / Terminated

FDA source

Richard Wolf Medical Instrument Corp began a recall of 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... on 2003-10-09. The reason FDA records is "The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0081-04
Status: Terminated
Initiated: 2003-10-09
Posted: 2004-07-20
Terminated: 2004-02-10
Recalling firm: Richard Wolf Medical Instruments Corp.
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
Product code: FFK--
Reason for recall: The sonotrode tube could become blocked by the stone fragments, causing overheating and damage to the device.
FDA root 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.
Product codes and lots: Model 8963.535, lot number M000580

Product code FFK--

K011065Class IIIntracorporeal Ultrasound Lithotripter, Model 2271.004, Ultrasound Transducer, Model 2271.501, Ultrasound Probes (Sono)Richard Wolf Medical Instruments Corp. / cleared 2001-05-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)