Events

Recall of Device Recall LT CAGE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Warsaw Orthopedic, 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
    32281
  • Event Risk Class
    Class 2
  • Event Number
    Z-1090-05
  • Event Initiated Date
    2005-05-27
  • Event Date Posted
    2005-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39507
  • 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
    Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
  • Reason
    The product is labeled as sterile, but this lot was not sterilized.

Device

Device Recall LT CAGE
  • Model / Serial
    Lot W05C5509.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States and Canada.
  • Product Description
    Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423.
  • Manufacturer
    Warsaw Orthopedic, Inc.

Manufacturer

Warsaw Orthopedic, Inc.
  • Manufacturer Address
    Warsaw Orthopedic, Inc., 2500 Silveus Xing, Warsaw IN 46582-8598
  • Source
    USFDA