Events

Recall of Device Recall ICON

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
    52051
  • Event Risk Class
    Class 2
  • Event Number
    Z-1655-2009
  • Event Initiated Date
    2009-05-21
  • Event Date Posted
    2009-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-04-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81992
  • 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
    spinal implants - Product Code MNI
  • Reason
    Product marketed without an approved 510(k).
  • Action
    Blackstone issued the recall notice to distributors by FedEx and email on May 21, 2009. This notification provides instructions to the field representatives how to return the product to Blackstone Medical. The Dear Doctor (Surgeon) letters are being sent Tues, May 26, 2009.

Device

Device Recall ICON
  • Model / Serial
    All lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Blackstone Medical: || ICON Modular Pedicle Screw System; || P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants.
  • Manufacturer
    Blackstone Medical, Inc.

Manufacturer

Blackstone Medical, Inc.
  • Manufacturer Address
    Blackstone Medical, Inc., 1211 Hamburg Tpke, Suite 300, Wayne NJ 07470
  • Manufacturer Parent Company (2017)
    Orthofix Medical, Inc.
  • Source
    USFDA