Events

Recall of Device Recall Spinal Concepts polyaxial screw driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer 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
    54143
  • Event Risk Class
    Class 2
  • Event Number
    Z-0603-2011
  • Event Initiated Date
    2005-12-01
  • Event Date Posted
    2010-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87613
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    The devices may fracture, resulting in surgical delay or the need for intervention to remove fragments from the surgical site.
  • Action
    The affected instruments were removed and replaced in the U.S. Abbott Spine and Spinal Concepts instrument kits between December 2005 and October 2007. User accounts were not advised of the removal Zimmer has confirmed that none of these instruments are currently available for use in the U.S. For further information about this action, contact Dale Miller of Zimmer at 574 372-4962.

Device

Device Recall Spinal Concepts polyaxial screw driver
  • Model / Serial
    Lots 16HU, 18FL, 19GC, 21BS and 29CK.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution, including US.
  • Product Description
    Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA