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.
FDA Recall Z-0921-03 · Posted 2003-07-29
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Recalling FirmStryker Instruments, Instruments Div.
Recall StatusTerminated
Date Initiated2003-06-01
Date Terminated2003-11-13
Product Quantity440 boxes
Reason for Recall
Non-sterilized product sold as sterile.
Firm 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
Root Cause
Other
Distribution Pattern
United States, Canada, Italy, Japan and United Kingdom
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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