Events

Recall of OsteoPack 3 FZ 22cc. 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-0491-06
  • 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=42953
  • 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

OsteoPack 3 FZ 22cc. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, ...
  • Model / Serial
    2726001 2726002 2726003 2730281 2730282 2730283
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Products were distributed worldwide.
  • Product Description
    OsteoPack 3 FZ 22cc. 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