Events

Recall of Device Recall Nexus or Geo

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Interpore Cross International 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
    30997
  • Event Risk Class
    Class 2
  • Event Number
    Z-0530-05
  • Event Initiated Date
    2005-01-14
  • Event Date Posted
    2005-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36952
  • 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
    Spinal Vertebral Body Replacement Device - Product Code MQP
  • Reason
    Mislabeled.
  • Action
    Firm sent recall letters on 1/18/2005 requesting return of product. A response form was enclosed.

Device

Device Recall Nexus or Geo
  • Model / Serial
    NEXUS Product List Of Catalog Numbers & Lot Numbers     Catalog Number Lot Number/s 1000-3000 300510  303512A  302909A  303012  302812A  302912  302109  303009 1000-3001 326408A  304009  304509 1000-3003 301210  305809A  305509  304709A  305109  324508 1000-3004 304011A  310110  303911A 1000-3005 304211A  312410  301112  304311 1000-3010 302407  300404 1000-3011 313207 1000-3013 307404  312107  312307A 1000-3015 306911A  309505  305605  305905  307111
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TN, MT, MI, CA, IN, PA, NJ, TX, KY, LA, CO.
  • Product Description
    Spinal Implant, || Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers)
  • Manufacturer
    Interpore Cross International Inc

Manufacturer

Interpore Cross International Inc
  • Manufacturer Address
    Interpore Cross International Inc, 181 Technology Dr, Irvine CA 92618-2402
  • Source
    USFDA