Events

Recall of ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127.

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
    30854
  • Event Risk Class
    Class 2
  • Event Number
    Z-0448-05
  • Event Initiated Date
    2005-01-04
  • Event Date Posted
    2005-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36713
  • 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
    Screw, Fixation, Bone - Product Code HWC
  • Reason
    The hex head of the screw driver may be too large to fit the screw heads iof the bone screws included in the kit.
  • Action
    Consignees were notified, via a recall letter dated 12/27/04 and issued on 1/4/05, to return the product. Competent Authorities were notified via letter dated 1/12/05.

Device

ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head sc...
  • Model / Serial
    Lots 634560 and 802080.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Belgium, Croatia, Denmark, Finland, France, Hong Kong, India, Jamaica, Netherlands, Nicaragua, Portugal, Romania and Russia.
  • Product Description
    ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127.
  • Manufacturer
    Warsaw Orthopedic, Inc.

Manufacturer

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