Events

Recall of Product is OPTEFIL Allograft Paste, Syringe 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-0499-06
  • 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=42970
  • 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, Syringe of varying sizes. Product is labeled in part: ''***...
  • Model / Serial
    2984056 2984062 2984064 2984065 2984067 2986825 2986827 2986829 2995321 2995322 2995323 2995324 2995325 2995326 2995327 2995328 2995329 2995330 2999692 2999693 2999694 2999695 2999696 2999697 2999698 2999699 2999700 2999924 2999925 2999926 2999927 2999928 2999929 2713387 2718732 2718736 2718737 2718738 2559751 2559752 2559753 2559754 2559755 2559756 2559757 2559758 2559759 2559760 2560031 2560032 2560033 2560034 2560035 2560036 2560037 2560038 2560039 2560040 2560271 2560272 2610521 2610522 2610523 2610524 2610525 2610526 2610527 2610528 2610529 2610530 2610541 2610542 2610543 2610544 2610545 2610546 2610547 2610548 2610549 2610550 2610581 2610582 2610583 2610584 2610585 2610586 2610601 2610602 2610603 2610604 2610605 2610606 2610607 2610608 2610609 2610610 2610611 2610612 2610613 2610614 2610615 2610616 2610617 2610618 2610619 2610620 2610761 2610762 2610763 2610764 2610765 2610766 2610767 2610768 2610769 2610770 2666740 2666741 2666742 2666743 2666744 2666745 2666746 2666747 2666748
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Products were distributed worldwide.
  • Product Description
    Product is OPTEFIL Allograft Paste, Syringe 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