X-STOP® Interspinous Spacer 1-3212 (UDI 00613994598745)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994598745), received between Mar 10, 2017 and Apr 21, 2017 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY, DUE TO LUMBAR SPINAL CANAL STENOSIS, IN WHICH IMPLANTATION TOOK PLACE AT LEVEL L3-4. POST OPERATIVELY THE PATIENT REPORTED HEALTH DAMAGE. THERE WAS NO CHANGE IN ZURICH CLAUDICATION SCORE (ZCQ).

  Patient problems: Stenosis

  MAUDE report 6510187 ↗
• InjuryMar 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REPORTED FROM THE PATIENT¿S 3 YEARS POSTOPERATIVE CRF :BUTTOCK PAIN AND LEFT LEG PAIN WERE CONFIRMED TO BE IMPROVED (DATE OF FOLLOW-UP WAS UNKNOWN).

  Patient problems: Inadequate Pain Relief

  MAUDE report 6394180 ↗

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