Events

Recall of Device Recall X STOP

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Francis Medical Technologies Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35621
  • Event Risk Class
    Class 2
  • Event Number
    Z-1258-06
  • Event Initiated Date
    2006-06-06
  • Event Date Posted
    2006-07-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46489
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Interspinous Process Decompression (IPD) System - Product Code NQO
  • Reason
    Some units may be mislabeled as 10 mm x stop implant that actually contain 14 mm x stop implant.
  • 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.

Device

Device Recall X STOP
  • Model / Serial
    Lot numbers 051122, 060126, 060213, 060306, 060322, 060405, 060413, 060420, 060504, 060509
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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
  • Manufacturer
    St. Francis Medical Technologies Inc

Manufacturer

St. Francis Medical Technologies Inc
  • Manufacturer Address
    St. Francis Medical Technologies Inc, 960 Atlantic Ave 102, Alameda CA 94501
  • Source
    USFDA