Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement Cartridge with Break-Away Femoral Nozzle for use with Str
FDA device recall Z-0921-03 · posted 2003-07-29 · Terminated
Recall details
- Recalling firm
- Stryker Instruments, Instruments Div.
- Reason for recall
- Non-sterilized product sold as sterile.
- Action taken
- 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
- Status
- Terminated
- Quantity affected
- 440 boxes
- Distribution
- United States, Canada, Italy, Japan and United Kingdom
- Date initiated
- 2003-06-01
- Date posted
- 2003-07-29
- Date terminated
- 2003-11-13
- Location
- Kalamazoo, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST (K912190) | Stryker Corp. | 1991-08-29 |