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.
FDA Recall Z-1106-2008 · Posted 2008-05-01
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeJDZ
Date Initiated2008-01-10
Date Terminated2008-07-31
Product Quantity25 boxes of 6 each
Reason for Recall
Sterility may be compromised, as the packaging may have channels in the packaging seal.
Firm Action
Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.