Recall Z-0502-06 ยท MQP Spinal Vertebral Body Replacement Device
Abbott Spine
TraXis Vue Spinal Implant System, Part #2601-090921
| Date | Feb 7, 2006 (initiated Nov 2, 2005) |
| Status | Terminated |
| Reason | Implants were manufactured without radiographic markers. |
| Root cause | Other |
| Action | Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected lot. |
| Quantity | 41 units |
| Distribution | Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031855 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM Spinal Concepts, Inc., Sep 17, 2003 |