Z-1195-2008

Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker PCD Precision System...

Name: Z-1195-2008 Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker PCD Precision System...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2008-02-13
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-02-13 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker... on 2008-02-13. The reason FDA records is "Mis-labeing; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)". 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-1195-2008
Status: Terminated
Initiated: 2008-02-13
Posted: 2008-03-11
Terminated: 2008-12-30
Recalling firm: Stryker Corp.
Product: Stryker VertePort , 11 G Cement Cannula, REF 306-510 , Qty 18; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.
Product code: JDZ Mixer, Cement, For Clinical Use
Reason for recall: Mis-labeing; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Consignees were notified via Medical Device Recall Notification letter dated 2/13/08 to read the enclosed instructions for use, remove all old instructions for use at the consignee location and replace them with the new instructions for use, and to discard the old instructions for use.
Quantity in commerce: 953 boxes Recalls Z-1192-1195-2008
Distribution: Nationwide.
Product codes and lots: All Lots-BB43, BDL5, BE0M, BE1D, BE77, BF4K, BMWJ, BNW8, BNW9 and BQ5W

Product code JDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)