Z-2294-2008

Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a...

Name: Z-2294-2008 Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2008-06-05
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-06-05 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a tracker intended for patient tracking during... on 2008-06-05. The reason FDA records is "Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures". 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-2294-2008
Status: Terminated
Initiated: 2008-06-05
Posted: 2008-09-16
Terminated: 2009-12-01
Recalling firm: Stryker Corp.
Product: Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a tracker intended for patient tracking during computer aided orthopaedic and trauma applications.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Consignees were notified via letter dated 6/5/08 providing them with additional warnings and instructions for use for these products. Contact Stryker Customer Service at 1-800-800-4236, ext. 3808.
Quantity in commerce: 28,861 boxes of all products.
Distribution: Nationwide, Austria, Australia, Brazil, Canada, China, Dubai, England, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Singapore, South Africa, South Korea, Sweden, Switzerland and Taiwan.
Product codes and lots: All units distributed prior to 6/5/08.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)