Events

Recall of Prestige Cervical Disc System, Implant Trial

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
    44953
  • Event Risk Class
    Class 2
  • Event Number
    Z-0141-2008
  • Event Initiated Date
    2007-09-04
  • Event Date Posted
    2007-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64588
  • 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
    Cervical Disc System - Product Code MJO
  • Reason
    Implant mis-seating; variance in size between the trial and the implant could cause the implant to be improperly seated.
  • Action
    The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.

Device

Prestige Cervical Disc System, Implant Trial
  • Model / Serial
    Lot Numbers: CN06M012, CN07A025, 434167, 510185, 511648, 510180, 511650, 510189, 515311, 513692, 521191, 523113, 421195 and 521188
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972247, SIZE 7 X 14, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
  • 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