Recall Z-0967-2011
Spine Wave Inc · initiated October 22, 2010
Product
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 bilaterally and used with autograft or allograft and supplemental spinal fixation. The supplemental fixation system that is intended to be used with the StaXx XD System is the CapSure PS Spine System.
Codes / lots: Lot #572H09 Use by 2012-06
Reason for recall
Package Insert Incorrect
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0967-2011
- Initiated
- October 22, 2010
- Posted by FDA
- January 26, 2011
- Terminated
- March 15, 2011
- Quantity
- 12 units
- Distribution
- Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York
- Recalling firm
- Spine Wave Inc, Shelton, CT