Events

Recall of NonAbsorbable Barrier Membrane

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Osteogenics Biomedical, 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
    75119
  • Event Risk Class
    Class 2
  • Event Number
    Z-0113-2017
  • Event Initiated Date
    2016-09-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149396
  • 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
    The device has the potential to be packaged in the wrong product box.
  • Action
    Osteogenics Biomedical sent an Urgent Customer Notification letter dated September 7, 2016, to all affected customers. This recall has been extended to the user level (clinician). All units sold domestically were to the end users (clinicians). End users were instructed to inspect inventory and return any affected product. For further questions, please call 1-888- 796-1923.

Device

NonAbsorbable Barrier Membrane
  • Model / Serial
    Lot 47295
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
  • Product Description
    Cytoplast Titanium-Reinforced Posterior Singles Membrane || A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
  • Manufacturer
    Osteogenics Biomedical, Inc.

Manufacturer

Osteogenics Biomedical, Inc.
  • Manufacturer Address
    Osteogenics Biomedical, Inc., 4620 71st St, Bldg 75-77, Lubbock TX 79424-2230
  • Manufacturer Parent Company (2017)
    Osteogenics Biomedical Inc
  • Source
    USFDA