BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0700-06 · Initiated October 14, 2005

    Recall

    Recall Number
    Z-0700-06
    Event Number
    34367
    Firm
    Regeneration Technologies, Inc.
    FEI Number
    3002719998
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 14, 2005
    Posted
    March 28, 2006
    Terminated
    August 7, 2012
    Address
    11621 Research Circle, Alachua, FL, 32615

    Description

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

    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.

    Distribution

    Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.

    Quantity

    235