Events

Recall of Device Recall Spineology Platen

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by The Spineology Group.

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
    31198
  • Event Risk Class
    Class 3
  • Event Number
    Z-0679-05
  • Event Initiated Date
    2005-01-28
  • Event Date Posted
    2005-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37373
  • 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
    Orthopedic Manual Surgical Instrument - Product Code LXH
  • Reason
    Three malfunctions, due to jamming of bone material in the fill tube occurred, which allowed the fill tube to advance more deeply than intended into the surgical site. fill tubes are used in delivery of bone graft materials.
  • Action
    A Product Update, January 2005 (Vol. 2) was e-mailed to all representatives and also sent by mail on January 28, 2005. Telephone calls to each distributor/representative were made by Spineology Sales & Marketing staff between January 28 and January 31. The Product Update informs customers that they will be receiving new tubes and new platens soon and that any tubes and platens currently in their possession should be returned to Spineology.

Device

Device Recall Spineology Platen
  • Model / Serial
    UT04005
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    11 consignees located in: Arkansas, Arizona, California, Georgia, Illinois, Michigan, Minnesota, North Carolina, New York, Oklahoma and United Kingdom
  • Product Description
    Platen, Catalog # 301-124, is a mechanism used to lock or hold the fill tube in place as it is filled with graft material. Platen is identified with Spineology, catalog number and lot number printed directly onto the metal.
  • Manufacturer
    The Spineology Group

Manufacturer

The Spineology Group
  • Manufacturer Address
    The Spineology Group, 1815 Northwestern Ave S, Stillwater MN 55082-6500
  • Source
    USFDA