FDA Recall
Terminated
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.
Recall: Z-0921-03
·
Initiated June 1, 2003
Recall
- Recall Number
- Z-0921-03
- Event Number
- 26415
- Firm
- Stryker Instruments, Instruments Div.
- FEI Number
- 1811755
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 1, 2003
- Posted
- July 29, 2003
- Terminated
- November 13, 2003
- Address
- 4100 E. Milham, Kalamazoo, MI, 49001
Description
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
Non-sterilized product sold as sterile.
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
Distribution
United States, Canada, Italy, Japan and United Kingdom
Quantity
440 boxes