Recall Z-0231-04 ยท HAW Neurological Stereotaxic Instrument
Medtronic Surgical Navigation Tech, Inc
Fix pins associated with Stealth Station Treatment Guidance Platform
| Date | Dec 17, 2003 (initiated Oct 31, 2003) |
| Status | Terminated |
| Reason | Surgical devices intended for single use were not labeled for single use. |
| Root cause | Other |
| Action | Consignees were notified by letter on 11/01/2003. |
| Quantity | 127 devices |
| Distribution | Domestic distribution to CA,FL,GA,KS,TX. Foreign distribution to Belgium, France, Germany, Hong Kong, Japan. No military or government consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001153 | MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM Medtronic Surgical Navigation, May 3, 2000 |
| K012937 | KNEE MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies, Jan 25, 2002 |
| K021980 | HIP MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies, Nov 19, 2002 |
| K030552 | IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies, Mar 19, 2003 |