Events

Recall of Device Recall Colorado 2 Anterior Plate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Sofamor Danek USA 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
    37376
  • Event Risk Class
    Class 2
  • Event Number
    Z-0653-2007
  • Event Initiated Date
    2007-02-02
  • Event Date Posted
    2007-03-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50447
  • 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 - Product Code KWQ
  • Reason
    Bone screws may pull though the plate.
  • Action
    Medtronic Global Quality initiated the recall via letter on 02/02/2007. Sub-recalls will be managed by Medtronic EMEA quality (Europe, Middle East, and Africa) in the affected geographies. Distributors and surgical facilities will be contacted as well as regulatory bodies in each country.

Device

Device Recall Colorado 2 Anterior Plate
  • Model / Serial
    Lot Nos.: 42554, 59143, 74708, 076380, 076520, 81321, 82118, 82119, 82236, 83602, 83667, 98552, 177390, 177420, 229470, 230050, 365740, 662340, 685000, 857100, 877430, 909610, W05A1351, W05C5778, W05F5388, W05F5389, W05G1030, W05G2592, W05H1354, W05H7884, W05J1023, W05J1497, W05J1687, W05J2710, W05J2711, W05L0550, W05L1016, W06E3829, W06F4111, W06H1671, W06K1299, W06M1486, W06M1487.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    France, Germany, Italy, UK, and Tunisia. No US distribution.
  • Product Description
    Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Indiana USA, Rx only
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Manufacturer Address
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132-1719
  • Source
    USFDA