Events

Recall of Device Recall Origen DBM with Bioactive Glass

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nanotherapeutics, 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
    60335
  • Event Risk Class
    Class 2
  • Event Number
    Z-0347-2012
  • Event Initiated Date
    2011-03-10
  • Event Date Posted
    2011-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105049
  • 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
    Filler, bone void, calcium compound - Product Code MQV
  • Reason
    On 03/10/2011 nanotherapeutics inc, alachua, fl initiated a recall of their origen dbm with bioactive glass catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). the same product is also distributed as nanofuse dbm catalog # nan109-02 (2cc) nan109-05 (5cc) and nan109-10(10cc). the products were manufactured without an approved 510k. direct accounts were notified of the recall on 04/08/2011.
  • Action
    Nanotherapeutics sent an Urgent: Medical Device Recall letter dated April 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove any unimplanted/unsold product shipped to them. Customers were asked to notify their customers and instruct them to make notification until the end user (hospital/physician) is reached. Recall Instructions: Immediately examine inventory and quarantine product subject to recall. Return all quarantined product subject to recall to: Nanotherapeutics, Inc. Attn: Receiving Department 13859 Progress Blvd, Suite 300 Alachua, Florida 32615 For questions call 386-462-9663

Device

Device Recall Origen DBM with Bioactive Glass
  • Model / Serial
    Catalog # NAN109-02, Lot #: 074349P.  Catalog # NAN109-05, Lot #: 073995PA, 077870PB.  Catalog # NAN109-10, Lot #: 071045PB, 071043PA, 070916P.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.
  • Product Description
    Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" || Product is labeled in part - Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615***Rx Only***ONE EACH***" || NanoFUSE DBM Catalog #: || NAN109-02 (2cc size) || NAN109-05 (5cc size) || NAN109-10(10cc size) || "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." || Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
  • Manufacturer
    Nanotherapeutics, Inc

Manufacturer

Nanotherapeutics, Inc
  • Manufacturer Address
    Nanotherapeutics, Inc, 13859 Progress Blvd Ste 300, Alachua FL 32615-9403
  • Manufacturer Parent Company (2017)
    Nanotherapeutics, Inc
  • Source
    USFDA