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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
St. Francis Medical Technologies Inc
Lot Codes / Batch Numbers
Lot numbers 051122, 060126, 060213, 060306, 060322, 060405, 060413, 060420, 060504, 060509
Products Sold
Lot numbers 051122, 060126, 060213, 060306, 060322, 060405, 060413, 060420, 060504, 060509
St. Francis Medical Technologies Inc is recalling St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm due to Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026