FDA Medical Device Recalls (openFDA)
St. Francis Medical Technologies Inc: 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
- Recall number
- Z-1258-06
- Recalling firm
- St. Francis Medical Technologies 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
- Status
- Terminated
- Initiated
- 2006-06-06
- Posted
- 2006-07-26
- Terminated
- 2006-11-21
- Reason
- Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.
- 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
- 4 units
- Distribution
- Worldwide
- Lot, serial or model codes
- Lot numbers 051122, 060126, 060213, 060306, 060322, 060405, 060413, 060420, 060504, 060509
- 510(k) numbers
- not on file
- PMA numbers
- ["P040001"]
- Product code
- NQO
- Firm FEI
- 3004904811
- Firm city
- Alameda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28