Events

Recall of Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

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
    34004
  • Event Risk Class
    Class 3
  • Event Number
    Z-0498-06
  • Event Initiated Date
    2005-10-14
  • Event Date Posted
    2006-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42969
  • 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 FedEx. 10/14/2005

Device

Product is OPTEFIL Allograft Paste of varying sizes. Product is labeled in part: ''***Processed...
  • Model / Serial
    3043361 3043362 3043364 3043365 3043366 3043367 3043368 3043369 3043370 3043441 3043443 3043445 3043446 3043471 3043472 3043473 3043475 3043476 3043477 3043479 3026931 3026932 3026934 3026935 3026937 3026939 3027181 3027185 3027187 3027189 3027462 3027463 3032194 3032196 3032200 3034771 3034776 3034777 3034779 3034780 3034851 3034852 3034853 3034854 3034855 3034857 3034858 3034859 3034860 3035411 3035412 3035414 3035415 3035416 3035417 3035418 3035420 3035951 3035952 3035953 3035954 3035959
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Products were distributed worldwide.
  • Product Description
    Product is OPTEFIL Allograft Paste of varying sizes. 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