Z-1073-2007

Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL...

Name: Z-1073-2007 Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL...
Creator: Gyrus ACMI Corporation
Published: 2007-05-23
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2007-05-23 / Terminated / root cause: sterility

FDA source

Gyrus ACMI Corporation began a recall of Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder... on 2007-05-23. The reason FDA records is "Sterilization Instructions not adequate for sterilizing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1073-2007
Status: Terminated
Initiated: 2007-05-23
Posted: 2007-08-09
Terminated: 2010-05-25
Recalling firm: Gyrus ACMI, Inc.
Product: Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray
Product code: FFK Lithotriptor, Electro-Hydraulic
Reason for recall: Sterilization Instructions not adequate for sterilizing.
Root cause tag: sterility
FDA root cause: Other
Action: Gyrus has informed their sales force to visit each customer that has a CyberWand system(s) and hand deliver a letter, dated May 23, 2007, that explains the situation and requests that the customer cease using the unit and segregate it to prevent accidental use. The letter also explains that the firm is collecting any sterilization trays with printed sterilization instructions and replacing them. The rep will assist the customer in complying. The customer will also be required to complete a reply form to track compliance.
Quantity in commerce: 53 units
Distribution: Nationwide and Canada.
Product codes and lots: Product distributed prior to May 7, 2007.

Product code FFK

K052135Class IICybersonics Cyberwand Dual Probe LithotripterCybersonics, Inc. / cleared 2005-12-20

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)