Recall Z-0654-2007 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Medtronic Sofamor Danek USA Inc
Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only
| Date | Mar 27, 2007 (initiated Feb 2, 2007) |
| Status | Terminated |
| Reason | Bone screws may pull though the plate. |
| Root cause | Other |
| Action | Medtronic Global Quality initiated the recall via letter on 02/02/2007. Sub-recalls will be managed by Medtronic EMEA quality (Europe, Middle East, and Africa) in the affected geographies. Distributors and surgical facilities will be contacted as well as regulatory bodies in each country. |
| Quantity | 293 units |
| Distribution | France, Germany, Italy, UK, and Tunisia. No US distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.