Z-1189-2012

Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held...

Name: Z-1189-2012 Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held...
Creator: Medtronic Navigation, Inc.
Published: 2012-02-06
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2012-02-06 / Terminated / root cause: design

FDA source

Medtronic Navigation, Inc. began a recall of Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of... on 2012-02-06. The reason FDA records is "When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1189-2012
Status: Terminated
Initiated: 2012-02-06
Posted: 2012-03-08
Terminated: 2012-03-26
Recalling firm: Medtronic Navigation, Inc
Product: Left Long Tactile Probe, Part #962009S, 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: When subjected to bending, twisting, and malleting, the probe tips break off when used in the sacrum for which they are not indicated for use. These probes are approved for use in the lumbar vertebra.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent - Product Safety Notice customer letter was sent via FED EX on 2/6/12 and 2/6/12 to direct consignees in the US identifying the affected product and the issue with it. The letter states that Medtronic Navigation is removing the product from clinical use and will provide a sales credit to customers. In the letters to Medtronic field personnel, it states that local sales and service personnel will be identified to remove the affected product from customer sites and return them for scrapping. Customers are to contact a sales representative if they have any questions regarding the letter.
Quantity in commerce: 6 units
Distribution: Worldwide Distribution -- US and Republic of South Korea.
Product codes and lots: Part Number 962009S: Lot Numbers 090106, 090407, 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)