Class 2 Device Recall X STOP

• Date Initiated by Firm: June 06, 2006
• Date Posted: July 26, 2006
• Recall Status: Terminated on November 21, 2006
• Recall Number: Z-1258-06
• Recall Event ID: 35621
• PMA Number: P040001
• Product Classification: Interspinous Process Decompression (IPD) System - Product Code NQO
• Product: St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew. Product is distributed by St. Francis Medical Technologies, Inc., 960 Atlantic Avenue, Suite 102, Alameda, CA 94501
• Code Information: Lot numbers 051122, 060126, 060213, 060306, 060322, 060405, 060413, 060420, 060504, 060509
• Recalling Firm/ Manufacturer: St. Francis Medical Technologies Inc; 960 Atlantic Ave 102; Alameda CA 94501
• For Additional Information Contact: Stephan Buttron; 510-337-2616
• Manufacturer Reason for Recall: Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.
• FDA Determined Cause: Other
• Action: On May 22, 2006, the firm initiated the recall and notification via letters explaining the reason for the recall and requesting the product be returned.
• Quantity in Commerce: 4 units
• Distribution: Worldwide
• Total Product Life Cycle: TPLC Device Report

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.

• PMA Database: PMAs with Product Code = NQO