Events

Recall of Device Recall Tissue regeneration barrier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by QLT USA, 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
    34506
  • Event Risk Class
    Class 2
  • Event Number
    Z-0476-06
  • Event Initiated Date
    2006-01-26
  • Event Date Posted
    2006-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43973
  • 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 Grafting Material, Synthetic - Product Code LYC
  • Reason
    Injectable needles were included in procedure kits instead of sterile blunt cannulas.
  • Action
    Consignee was notified by letter on 1/26/2006.

Device

Device Recall Tissue regeneration barrier
  • Model / Serial
    Lot 2072A, Exp 5/2007
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    PA
  • Product Description
    Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
  • Manufacturer
    QLT USA, Inc.

Manufacturer

QLT USA, Inc.
  • Manufacturer Address
    QLT USA, Inc., 701 Centre Avenue, Fort Collins CO 80526-1843
  • Source
    USFDA