Z-0923-2010

Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In combination...

Name: Z-0923-2010 Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In combination...
Creator: Medtronic Navigation, Inc
Published: 2009-11-03
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2009-11-03 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Navigation, Inc began a recall of Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In combination with a tera-tracker reference frame, is used by an... on 2009-11-03. The reason FDA records is "Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0923-2010
Status: Terminated
Initiated: 2009-11-03
Posted: 2010-03-03
Terminated: 2010-08-13
Recalling firm: Medtronic Navigation, Inc
Product: Medtronic Orthopedic Dovetail Clamp, REF 9730289, Medtronic Navigation, Louisville, CO 80027. In combination with a tera-tracker reference frame, is used by an Orthopedic surgeon to navigate the location of an acetabular cup positioner/impactor during hip replacement surgery.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Orthopedic clamp may slip if used with non-indicated system, resulting in possible inaccurate navigation information being displayed.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: All affected users were notified by a Product Correction Notification letter on 11/03/2009 providing a description of the issue and informing them of the updated instructions for use for the Orthopedic Dovetail Clamp. Customers are to ensure that all users read the letter, place a copy of the letter with the IFUs for the related software applications listed in the letter, and fill out the attached response form indicating the receipt of the information. Further information is available at 720-890-3309.
Quantity in commerce: 244 units
Distribution: Worldwide Distribution -- USA, including VA, IA, MN and OK and countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Hong Kong, Iceland, India, Israel, Italy, Japan, Korea, Lebanon, Malta, Mexico, Netherlands, Poland, Russian Federation, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, and UK.
Product codes and lots: All lot numbers.

Product code HAW

K021980Class IIHip Module for the Stealthstation SystemMedtronic Surgical Navigation Technologies / cleared 2002-11-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)