Z-0231-04

Fix pins associated with Stealth Station Treatment Guidance Platform

Name: Z-0231-04 Fix pins associated with Stealth Station Treatment Guidance Platform
Creator: Medtronic Surgical Navigation Tech, Inc
Published: 2003-10-31
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2003-10-31 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Surgical Navigation Tech, Inc began a recall of Fix pins associated with Stealth Station Treatment Guidance Platform on 2003-10-31. The reason FDA records is "Surgical devices intended for single use were not labeled for single 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-0231-04
Status: Terminated
Initiated: 2003-10-31
Posted: 2003-12-17
Terminated: 2003-12-19
Recalling firm: Medtronic Navigation, Inc
Product: Fix pins associated with Stealth Station Treatment Guidance Platform
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Surgical devices intended for single use were not labeled for single use.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter on 11/01/2003.
Quantity in commerce: 127 devices
Distribution: Domestic distribution to CA,FL,GA,KS,TX. Foreign distribution to Belgium, France, Germany, Hong Kong, Japan. No military or government consignees.
Product codes and lots: 3'' fix pin - 9730476, Lot numbers 200302130552, 200302140566 and 200302260619. 5'' fix pin - 9730477, Lot numbers200302140564, and 200303030641.

Product code HAW

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)