BEUDAMED
    FDA Enforcement Class II Terminated

    RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications

    Recall: Z-1441-2017 · Reported March 22, 2017

    Enforcement

    Recall Number
    Z-1441-2017
    Event ID
    76473
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RTI Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 22, 2017
    Initiation Date
    January 23, 2017
    Classification Date
    March 10, 2017
    Termination Date
    April 5, 2018
    Address
    11621 Research Cir, N/A, Alachua, FL, 32615-6825, United States

    Description

    RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications

    Reason

    Incorrect instructions for use (IFU) included.

    Code Info

    Serial #'s: 30303308, 30303321, 30303327, 30303340, 3034313, 30304314, 30304330, 30401686, 30401699, 30401714, 30401721, 30401723, 30401730, 30401732, 30401735, 3041741, 30401746, 30401750, 30718244, 30718441, 30718442, 30718448, and 30718449.

    Distribution

    International Distribution: Colombia only

    Quantity

    24 units