Z-1106-2008

Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High...

Name: Z-1106-2008 Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2008-01-10
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-01-10 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF... on 2008-01-10. The reason FDA records is "Sterility may be compromised, as the packaging may have channels in the packaging seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1106-2008
Status: Terminated
Initiated: 2008-01-10
Posted: 2008-05-01
Terminated: 2008-07-31
Recalling firm: Stryker Corp.
Product: Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.
Product code: JDZ Mixer, Cement, For Clinical Use
Reason for recall: Sterility may be compromised, as the packaging may have channels in the packaging seal.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.
Quantity in commerce: 25 boxes of 6 each
Distribution: Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.
Product codes and lots: Lot Numbers: 05167CG2, 05192012, 05223012 and 06335012.

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)