Z-0967-2011

StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) Catalog number: 11-1525...

Name: Z-0967-2011 StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H) Catalog number: 11-1525...
Creator: Spine Wave Inc
Published: 2010-10-22
License: https://open.fda.gov/license/

Spine Wave Inc / initiated 2010-10-22 / Terminated / root cause: packaging

FDA source

Spine Wave Inc began a recall of 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... on 2010-10-22. The reason FDA records is "Package Insert Incorrect". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0967-2011
Status: Terminated
Initiated: 2010-10-22
Posted: 2011-01-26
Terminated: 2011-03-15
Recalling firm: Spine Wave Inc
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.
Reason for recall: Package Insert Incorrect
Root cause tag: packaging
FDA 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 in commerce: 12 units
Distribution: Nationwide Distribution including Delaware, Massachusetts, Maryland, and New York
Product codes and lots: Lot #572H09 Use by 2012-06

K101288Class IIStaxx Xd SystemSpine Wave, Inc. / cleared 2010-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)