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.
FDA Recall Z-0967-2011 · Posted 2011-01-26
Recalling FirmSpine Wave Inc
Recall StatusTerminated
Date Initiated2010-10-22
Date Terminated2011-03-15
Product Quantity12 units
Reason for Recall
Package Insert Incorrect
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.