Fix pins associated with Stealth Station Treatment Guidance Platform
FDA device recall Z-0231-04 · posted 2003-12-17 · Terminated
Recall details
- Recalling firm
- Medtronic Surgical Navigation Tech, Inc
- Reason for recall
- Surgical devices intended for single use were not labeled for single use.
- Action taken
- Consignees were notified by letter on 11/01/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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.
- Date initiated
- 2003-10-31
- Date posted
- 2003-12-17
- Date terminated
- 2003-12-19
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM (K030552) | Medtronic Surgical Navigation Technologies | 2003-03-19 |
| HIP MODULE FOR THE STEALTHSTATION SYSTEM (K021980) | Medtronic Surgical Navigation Technologies | 2002-11-19 |
| KNEE MODULE FOR THE STEALTHSTATION SYSTEM (K012937) | Medtronic Surgical Navigation Technologies | 2002-01-25 |
| MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM (K001153) | Medtronic Surgical Navigation | 2000-05-03 |