Events

Recall of Osteofil RT Allograft Paste

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Regeneration Technologies, 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
    34367
  • Event Risk Class
    Class 3
  • Event Number
    Z-0698-06
  • Event Initiated Date
    2005-10-14
  • Event Date Posted
    2006-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43644
  • 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
    The tissue was collected from donors for whom there is no verifiable identity or consent. the medical records and social histories of the donors cannot be ascertained. the devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.
  • Action
    Notification sent to all consignees by Fed Ex 10/14/2005.

Device

Osteofil RT Allograft Paste
  • Model / Serial
    1766813 1766814 1890442 1890445 1890446 1890447 1890450 1890451 1938863 1938864 1938865 1938868 1938869 1890448 1890449 1938862 1938866 1938870
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
  • Product Description
    Osteofil + RT Allograft Paste 10cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
  • Manufacturer
    Regeneration Technologies, Inc.

Manufacturer

Regeneration Technologies, Inc.
  • Manufacturer Address
    Regeneration Technologies, Inc., 11621 Research Circle, Alachua FL 32615
  • Source
    USFDA