Recall Z-1088-06 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Medtronic Sofamor Danek USA Inc
8mm SATELLITE Sphere CoCr contained in a SATELLITE Spinal System (internal fixation device-vertebral stabilization/fusion)
| Date | Jun 8, 2006 (initiated Jan 14, 2006) |
| Status | Terminated |
| Reason | Device distribution without marketing clearance |
| Root cause | Other |
| Action | The recalling firm sent out a letter notifying the implanting surgeon that he had implanted a device that was not approved for use. |
| Quantity | 1 unit |
| Distribution | LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051320 | SATELLITE SPINAL SYSTEM Medtronic Sofamor Danek, Sep 9, 2005 |