Z-0021-05

Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000

Name: Z-0021-05 Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000
Creator: Stryker Instruments, Instruments Div.
Published: 2004-07-14
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2004-07-14 / Terminated

FDA source

Stryker Instruments, Instruments Div. began a recall of Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000 on 2004-07-14. The reason FDA records is "The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0021-05
Status: Terminated
Initiated: 2004-07-14
Posted: 2004-10-19
Terminated: 2004-10-18
Recalling firm: Stryker Corp.
Product: Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
FDA root cause: Other
Action: Sales force was notified these pre-launch devices are not to be used for surgical use via e-mail and telephone calls on 7/14/04.
Distribution: United States.
Product codes and lots: Serial numbers PG04-0006 through PG04-0017.

Product code HAW

K022365Class IIStryker Navigation System - Hip ModuleStryker Instruments / cleared 2003-01-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)