Atlas FDA

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

FDA device recall Z-1106-2008 · posted 2008-05-01 · Terminated

Recall details

Recalling firm
Stryker Instruments Div. of Stryker Corporation
Reason for recall
Sterility may be compromised, as the packaging may have channels in the packaging seal.
Action taken
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
Status
Terminated
Product code
JDZ
Quantity affected
25 boxes of 6 each
Distribution
Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.
Date initiated
2008-01-10
Date posted
2008-05-01
Date terminated
2008-07-31
Location
Portage, MI

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