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U.S. Department of Health and Human Services

Class 2 Device Recall Spine Wave

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  Class 2 Device Recall Spine Wave see related information
Date Initiated by Firm October 22, 2010
Date Posted January 26, 2011
Recall Status1 Terminated 3 on March 15, 2011
Recall Number Z-0967-2011
Recall Event ID 57188
510(K)Number k101288  
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.
Code Information Lot #572H09 Use by 2012-06
Recalling Firm/
Spine Wave Inc
Two Enterprise Drive
Suite 302
Shelton CT 06484
For Additional Information Contact Ronald K. Smith
Manufacturer Reason
for Recall
Package Insert Incorrect
FDA Determined
Cause 2
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

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = and Original Applicant = SPINE WAVE, INC.