Z-1258-06

St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP...

Name: Z-1258-06 St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP...
Creator: St. Francis Medical Technologies Inc
Published: 2006-06-06
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-06-06 / Terminated / root cause: labeling and UDI

FDA source

St. Francis Medical Technologies Inc began a recall of 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... on 2006-06-06. The reason FDA records is "Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1258-06
Status: Terminated
Initiated: 2006-06-06
Posted: 2006-07-26
Terminated: 2006-11-21
Recalling firm: Medtronic, Inc.
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
Product code: NQO Prosthesis, Spinous Process Spacer/Plate
Reason for recall: Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.
Root cause tag: labeling and UDI
FDA root 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
Product codes and lots: Lot numbers 051122, 060126, 060213, 060306, 060322, 060405, 060413, 060420, 060504, 060509

Product code NQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)