Z-0002-2012

Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand...

Name: Z-0002-2012 Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand...
Creator: Medtronic Navigation, Inc
Published: 2011-01-20
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2011-01-20 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Navigation, Inc began a recall of Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for... on 2011-01-20. The reason FDA records is "Distal end of tactile probe may break off during use". 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-0002-2012
Status: Terminated
Initiated: 2011-01-20
Posted: 2011-10-03
Terminated: 2011-10-03
Recalling firm: Medtronic Navigation, Inc
Product: Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Distal end of tactile probe may break off during use.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Medtronic sent an "Urgent Product Safety Notice" to all affected customers dated Jan 20, 2011. The letter included affected product and updated instructions for use. On-site training was given for the use of the probes by Medtronic Representatives. For information on this recall call Medtronics at (720) 890-3409.
Quantity in commerce: 6 probes
Distribution: Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea
Product codes and lots: Lot Number 071219

Product code HAW

K990214Class IIFluoronav Module for the Stealthstation SystemSurgical Navigation Technologies, Inc. / cleared 1999-04-22

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)