Events

Recall of Device Recall Blackstone Medical Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Blackstone Medical 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
    34355
  • Event Risk Class
    Class 1
  • Event Number
    Z-0716-06
  • Event Initiated Date
    2005-12-23
  • Event Date Posted
    2006-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43614
  • 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
    Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
  • Reason
    Pedicle screw may disengage in post op period requiring intervention.
  • Action
    Blackstone Medical notified Distributors by email on 12/23/05 to quarantine inventory. A letter notifying physicans was issued 12/28/05 via Fed''X. Product is to be returned to Blackstone Medical.

Device

Device Recall Blackstone Medical Inc.
  • Model / Serial
    All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AL,CA, CO, IL, NH, NM, TX Foreign: BMI , Diessen, Germany
  • Product Description
    ICON Modular Spinal Fixation System used with the: || ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 || ICON Instrument Case 1 Item Number: 54-1091 || ICON Instrument Case 2 Item Number: 54-1092
  • Manufacturer
    Blackstone Medical Inc.

Manufacturer

Blackstone Medical Inc.
  • Manufacturer Address
    Blackstone Medical Inc., 90 Brookdale Drive, Springfield MA 01104-3206
  • Source
    USFDA