Events

Recall of Device Recall Ascent Posterior Occipital Cervical Thoracic System

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
    54507
  • Event Risk Class
    Class 2
  • Event Number
    Z-1144-2010
  • Event Initiated Date
    2010-02-02
  • Event Date Posted
    2010-03-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88603
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Reason
    The ascent posterior occipital cervical thoracic system single looped cable with two crimps may be made of stainless steel instead of titanium.
  • Action
    Orthofix Spinal Implants contacted customers by phone beginning December 22, 2009 and issued a Notification of Product Removal dated February 2, 2010. Consignees were instructed to Identify, Remove and Return all affected product to the firm. For further information, contact Orthofix Spinal Implants, Regulatory Affairs Department at 1-973-406-2812.

Device

Device Recall Ascent Posterior Occipital Cervical Thoracic System
  • Model / Serial
    Part Number: 65-2053, Lot Number: 047247.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.
  • Product Description
    Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. || Intended to promote fusion of the cervical spine and occipitothoracic junction.
  • 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