Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.
FDA device recall Z-0020-05 · posted 2004-10-19 · Terminated
Recall details
- Recalling firm
- Stryker Instruments, Instruments Div.
- Reason for recall
- The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
- Action taken
- Sales force was notified these pre-launch devices are not to be used for surgical use via e-mail and telephone calls on 7/14/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- HAW
- Distribution
- United States.
- Date initiated
- 2004-07-14
- Date posted
- 2004-10-19
- Date terminated
- 2004-10-18
- 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 NAVIGATION SYSTEM - HIP MODULE (K022365) | Stryker Instruments | 2003-01-22 |