Recall Z-0354-2007 ยท MQP Spinal Vertebral Body Replacement Device
Abbott Spine
TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system
| Date | Jan 17, 2007 (initiated Nov 7, 2006) |
| Status | Terminated |
| Reason | Tip of devices may dislodge while in use during surgery. |
| Root cause | Other |
| Action | All consignees that have the affected TraXis Fixed Rasps and TraXis Fixed Trials will be contacted via a documented phone script 11/07/2006. Affected inventory will be exchanged for re-worked instruments. |
| Quantity | 76 units. |
| Distribution | Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.