Events

Recall of Device Recall TSRH SiLo 5.5 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
    44787
  • Event Risk Class
    Class 2
  • Event Number
    Z-0074-2008
  • Event Initiated Date
    2007-08-24
  • Event Date Posted
    2007-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64361
  • 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 Fixation System - Product Code KWP
  • Reason
    Disassembly: the movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.
  • Action
    Medtronic sent letters, titled URGENT DEVICE RECALL, on 08/24/2007, to the Risk Managers of the hospital consignees explaining the potential for these sets to disassemble, and requesting the discontinuation of the use of and quarantine of the product. The product will be retrieved by the firm and replaced.

Device

Device Recall TSRH SiLo 5.5 Spinal System
  • Model / Serial
    Lot Numbers: 1964441, 2633734, 14372033, 1813832, 2751495, 14673943, 14178935, 14013412, 14013714, 14013977, 14014230, 14014405, 14011615, 14011836, 15001233, 15001383, 13990466, 14103373, 14103376.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, The Netherlands, Australia, and Canada.
  • Product Description
    Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sagittal Adjusting Screw Implants, Supplement Sets, REF: 8889245, Pedicle Screw Fixation System, Medtronic Sofamor Danek, Memphis, TN 38131
  • 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