Events

Recall of Device Recall SATELLITE Spinal System

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
    35261
  • Event Risk Class
    Class 2
  • Event Number
    Z-1088-06
  • Event Initiated Date
    2006-01-14
  • Event Date Posted
    2006-06-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45681
  • 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 fixation device - Product Code MAX
  • Reason
    Device distribution without marketing clearance.
  • Action
    The recalling firm sent out a letter notifying the implanting surgeon that he had implanted a device that was not approved for use.

Device

Device Recall SATELLITE Spinal System
  • Model / Serial
    Cat No. 8000208, Lot No. W05K0555
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    LA
  • Product Description
    8mm SATELLITE¿ Sphere CoCr contained in a SATELLITE¿ Spinal System (internal fixation device-vertebral stabilization/fusion)
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

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