Recall Z-0021-05 ยท HAW Neurological Stereotaxic Instrument
Stryker Instruments, Instruments Div.
Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000.
| Date | Oct 19, 2004 (initiated Jul 14, 2004) |
| Status | Terminated |
| Reason | The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system. |
| Root cause | Other |
| Action | 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. |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022365 | STRYKER NAVIGATION SYSTEM - HIP MODULE Stryker Instruments, Jan 22, 2003 |