Spine Wave Inc
StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) Catalog number: 11-1525 The StaXx XD System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace and restore height of a collapsed, damaged, or unstable vertebral body or portion thereof, due to tumor or trauma (i.e., fracture). The system is to be placed bilaterall
| Date | Jan 26, 2011 (initiated Oct 22, 2010) |
| Status | Terminated |
| Reason | Package Insert Incorrect |
| Root cause | Packaging process control |
| Action | Spine Wave notified each affected customer on October 22,2010, via telephone of the product, the issue and action they should take. Customers were asked to segregate the product from other products and immediately return to Spine Wave. For questions regarding this recall call 203-944-9494. |
| Quantity | 12 units |
| Distribution | Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101288 | STAXX XD SYSTEM Spine Wave, Inc., Sep 10, 2010 |