Events

Recall of Device Recall AntCer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spinal Concepts, 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
    28505
  • Event Risk Class
    Class 2
  • Event Number
    Z-0807-04
  • Event Initiated Date
    2004-03-01
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32010
  • 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
    Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
  • Action
    The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.

Device

Device Recall AntCer
  • Model / Serial
    All lots in the market.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
  • Manufacturer
    Spinal Concepts, Inc

Manufacturer

Spinal Concepts, Inc
  • Manufacturer Address
    Spinal Concepts, Inc, 5301 Riata Park Ct Bldg F, Austin TX 78727-3436
  • Source
    USFDA