St. Francis Medical Technologies brand X STOP Interspinous… recallZ-1258-06 · St. Francis Medical Technologies Inc · initiated Jun 6, 2006
Terminated All recalls posted in July 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from St. Francis Medical Technologies Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-1258-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 6, 2006
- Posted by the FDA
- Jul 26, 2006
- Recalling firm
- St. Francis Medical Technologies Inc
- Quantity
- 4 units
- Product code
- NQO
- FDA submissions
- P040001
- Distribution
- Worldwide
Product description
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 (models, lots, serial numbers)
Lot numbers 051122, 060126, 060213, 060306, 060322, 060405, 060413, 060420, 060504, 060509
Other devices under the same FDA submission
7 devices cleared under P040001 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- X-STOP® Interspinous Spacer 1-3210Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate5 reports
- X-STOP® Interspinous Spacer 1-3212Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate2 reports
- X-STOP® Interspinous Spacer 1-3212Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate2 reports
- X-STOP® Interspinous Spacer 1-3208Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate1 report
- X-STOP® Interspinous Spacer 1-2212Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate1 report
- X-STOP® Interspinous Spacer 1-3208Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate1 report
- X-STOP® Interspinous Spacer 1-3206Medtronic Sofamor Danek, Inc. · Prosthesis, spinous process spacer/plate1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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