Stryker Instruments, Instruments Div.
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.
| Date | Jul 29, 2003 (initiated Jun 1, 2003) |
| Status | Terminated |
| Reason | Non-sterilized product sold as sterile. |
| Root cause | Other |
| 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 |
| Quantity | 440 boxes |
| Distribution | United States, Canada, Italy, Japan and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912190 | STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST Stryker Corp., Aug 29, 1991 |