Events

Recall of Allogenix;

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
    45469
  • Event Risk Class
    Class 3
  • Event Number
    Z-0619-2008
  • Event Initiated Date
    2007-10-15
  • Event Date Posted
    2008-02-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65547
  • 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
    Bone Filler (Calcium) - Product Code MQV
  • Reason
    Unapproved testing: interpore cross international was recently informed that one of its human tissue suppliers, lifelink tissue bank ("lifelink"), utilized unapproved diagnostic testing (hbsag & hbc) on certain lots of distributed donor tissue instead of the fda approved screening test. as a result, interpore cross international has initiated a recall on specific lots of products containing human.
  • Action
    The Recall Notification letters will be sent via commercial carrier (UPS) with signature for verification of receipt required on Friday October 26, 2007, to all consignees, including hospitals and sales representatives, which summarizes the recall details and instructs the consignee to contact Interpore Cross via mail or facsimile with the enclosed Customer Response form, and to immediately return the affected product.

Device

Allogenix;
  • Model / Serial
    Serial Numbers: 079180 & 234760
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Allogenix; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: 02-3110, Interpore Cross International, a Biomet company (Allogenix DBM products contain human tissue (allograft bone) and are intended for transplantation)
  • 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