BEUDAMED
    FDA Recall Terminated

    Product is OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

    Recall: Z-0500-06 · Initiated October 14, 2005

    Recall

    Recall Number
    Z-0500-06
    Event Number
    34004
    Firm
    Regeneration Technologies, Inc.
    FEI Number
    3002719998
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 14, 2005
    Posted
    February 7, 2006
    Terminated
    July 26, 2012
    Address
    11621 Research Circle, Alachua, FL, 32615

    Description

    Product is OPTEFORM Allograft Full Disc, 5 x 90mm, 32cc, Frozen. 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 FedEx. 10/14/2005

    Distribution

    Products were distributed worldwide.