8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusio
FDA device recall Z-1088-06 · posted 2006-06-08 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- Device distribution without marketing clearance
- Action taken
- The recalling firm sent out a letter notifying the implanting surgeon that he had implanted a device that was not approved for use.
- Root cause
- Other
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 1 unit
- Distribution
- LA
- Date initiated
- 2006-01-14
- Date posted
- 2006-06-08
- Date terminated
- 2007-10-15
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SATELLITE SPINAL SYSTEM (K051320) | Medtronic Sofamor Danek | 2005-09-09 |