Events

Recall of Device Recall Ascent POCTS (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
    45523
  • Event Risk Class
    Class 2
  • Event Number
    Z-0363-2008
  • Event Initiated Date
    2007-05-15
  • Event Date Posted
    2007-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65731
  • 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
    Pedicle Screw Spinal System - Product Code MNI
  • Reason
    Manufacturing defect: the saddle of the screw's body relative to the keyway exceeds the tolerance outlined in the device specifications. the extent to which the tolerance is exceeded varies from part to part, in the extreme the tolerance is exceeded by (+) 50%. as a consequence, there is a potential for set-screw cross-threading during implantation. cross-threading could in turn lead to a comprom.
  • Action
    Blackstone Medical, Inc., field representatives were notified via phone, e-mail or fax on 4/30/07. Attention: Notification of Product Removal Letters were sent on May 15, 2007, to distributors and implanting surgeons requesting return of non-implanted stock.

Device

Device Recall Ascent POCTS (Posterior Occipital Cervical Thoracic System)
  • Model / Serial
    Part Numbers: 65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330; Lot numbers: 009, 010, 011, 018, 019, 031, 048, 064, 084 and 107.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide: USA and countries of China, Cyprus, Turkey and Switzerland.
  • Product Description
    Ascent POCTS (Posterior Occipital Cervical Thoracic System) Part Numbers: 65-33 XX Series (65-3310,-3312, -3314, -3318, -3320-, -3322, -3324, -3326, -3328, and -3330), Multi-Axial Screw, 4.0mm x 26mm;Implant grade Titanium Alloy; Blacksone Medical Inc., 90 Brookdale Drive, Springfield, MA 01104.
  • 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