X-STOP® Interspinous Spacer 1-2212Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169132719), received between Sep 17, 2018 and Sep 17, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P040001); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TREATMENT AT L4/L5 LEVELS. POST-OPERATIVELY, THE PATIENT BEGAN TO EXPERIENCE RECURRENCE OF NEUROGENIC CLAUDICATION. DIAGNOSTIC IMAGE STUDIES REVEALED DISPLACEMENT OF THE SPACER FROM THE INTERLAMINARY SPACE. AS A RESULT, A REVISION SURGERY WAS PERFORMED FOR REMOVAL FOLLOWED BY LUMBAR DECOMPRESSION AND IMPLANTATION OF A NEW SPACER. THE ALLEGED SPACER WAS REMOVED BY LOOSENING THE LOCKING SCREWS ON ONE OF THE WING CLAMPS AND REMOVED IN TWO PIECES AND REPORTEDLY INTACT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Claudication

  MAUDE report 7880043 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040001. One submission often covers many models, so check the product and lot details in each record.

• Z-1765-2008 · Jan 30, 2008 · Terminated
  X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers for X-STOP Titanium Imp
• Z-1258-06 · Jun 6, 2006 · Terminated
  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 b