Z-0921-03

Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for...

Name: Z-0921-03 Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for...
Creator: Stryker Instruments, Instruments Div.
Published: 2003-06-01
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2003-06-01 / Terminated / root cause: sterility

FDA source

Stryker Instruments, Instruments Div. began a recall of Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection... on 2003-06-01. The reason FDA records is "Non-sterilized product sold as sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0921-03
Status: Terminated
Initiated: 2003-06-01
Posted: 2003-07-29
Terminated: 2003-11-13
Recalling firm: Stryker Corp.
Product: Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum cement injection system, 6 pack; part 0306-563-000.
Reason for recall: Non-sterilized product sold as sterile.
Root cause tag: sterility
FDA root cause: Other
Action: Sales representatives were notified on June 1, 2003 and requested to contact their accounts to determine if any product remained on the shelf. Recall letters dated June 12, 2003 were sent to each customer''s risk manager, surgical director and hospital administrator via certified mail
Quantity in commerce: 440 boxes
Distribution: United States, Canada, Italy, Japan and United Kingdom
Product codes and lots: lot 03030232.

K912190Class IStryker High Vacuum Bone Cement Mixer/inject SystStryker Corp. / cleared 1991-08-29

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)