Z-0123-2010

Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF...

Name: Z-0123-2010 Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2009-10-26
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-10-26 / Terminated / root cause: software

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF 7700-101-201. The Stryker Navigation System II is a... on 2009-10-26. The reason FDA records is "Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0123-2010
Status: Terminated
Initiated: 2009-10-26
Posted: 2009-11-20
Terminated: 2009-12-31
Recalling firm: Stryker Corp.
Product: Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF 7700-101-201. The Stryker Navigation System II is a computer-aided surgery platform, supporting surgeons to perform surgical interventions.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.
Root cause tag: software
FDA root cause: Software design
Action: The firm issued a press release on 11/4/09. Consignees were notified by an Urgent: Medical Device Recall Notification letter dated 10/23/09, which advised of the affected products, the reason for the recall, the recall plan, and the actions to be taken. Customers were to immediately review this notification and distribute to all departments affected. Also, customers were to immediately quarantine any affected product and label as recalled product; complete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.
Quantity in commerce: 2 replacement systems
Distribution: Worldwide Distribution -- USA, including states of Florida, Kansas, Kentucky, Massachusetts, Michigan, New Jersey, Pennsylvania, South Carolina, Texas, and Washington and countries of Australia, China, Germany, Japan, Korea, Switzerland, and the United Kingdom.
Product codes and lots: Serial number K7P00F6000.

Product code HAW

K993239Class IIStryker Navigation System - Neuro Module, Model 6000-Xxx-XxxStryker Corp. / cleared 2000-01-18

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)