BEUDAMED
    FDA Recall 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 · Initiated January 23, 2017

    Recall

    Recall Number
    Z-1441-2017
    Event Number
    76473
    Firm
    RTI Surgical, Inc.
    FEI Number
    3002719998
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    January 23, 2017
    Terminated
    April 5, 2018
    Address
    11621 Research Cir, Alachua, FL, 32615-6825

    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.

    Action

    The firm, RTI Surgical, Inc., issued and "IMPORTANT NOTIFICATION Field Action" letter dated January 20th, 2017 to its consignee via e-mail on 01/23/2017. Verification and confirmation of the e-mail was received on the same date. The letter described the product, problem and actions to be taken. The consignee were instructed to immediately quarantine any grafts in your possession; return any unused RTI and include return authorization along with instructions on how to return the product. If you have any questions, Sr. Manager, Regulatory Compliance at 386-418-8888 ext. 4396 or email: [email protected].

    Distribution

    International Distribution: Colombia only

    Quantity

    24 units