Events

Recall of Device Recall Blackstone Medical Hallmark

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
    55002
  • Event Risk Class
    Class 2
  • Event Number
    Z-1653-2010
  • Event Initiated Date
    2010-03-15
  • Event Date Posted
    2010-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89667
  • 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 implant surgical instrument - Product Code KWQ
  • Reason
    The hallmark anterior cervical plate bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.
  • Action
    Orthofix send letters of notification of planned product removal to distributors who keep the instrumentation set on 3/29/2010 by Fed Ex. Letters of planned product removal explain the reason for the planned removal and the specific product involved. Replacement product will not be available until July 2010, however, the firm elected to notify customers of the potential problem and the date that formal notification and replacement Plate Benders will be available. Letters state that if there is any problem with the Plate Benders, questions can be directed to David Thompson in Marketing at 972-529-3024 or Jose Charvet in Product Development at 973-406-2824.

Device

Device Recall Blackstone Medical Hallmark
  • Model / Serial
    Part number 62-0070, all lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution, including Puerto Rico, and to Australia.
  • Product Description
    Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. || Non Sterile.
  • 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