BEUDAMED
    FDA Recall Terminated

    TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM MONO TIB STR GRN SZ 6 14MM - 00588606614 TM MONO TIB STR GRN SZ 6 17MM - 00588606617 TM MONO TIB STR BLUE SZ 7 10MM - 00588606710 TM MONO TIB STR BLUE SZ 7 12MM - 00588606712 TM MONO TIB STR BLUE SZ 7 14MM - 00588606714 TM MONO TIB STR BLUE SZ 7 17MM - 00588606717 TM MONO TIB STR GRN SZ 5 10MM - 00588607510 TM MONO TIB STR GRN SZ 5 12MM - 00588607512 TM MONO TIB STR GRN SZ 5 14MM - 00588607514 TM MONO TIB STR GRN SZ 5 17MM - 00588607517

    Recall: Z-1953-2016 · Initiated April 15, 2016

    Recall

    Recall Number
    Z-1953-2016
    Event Number
    73536
    Firm
    Zimmer Trabecular Metal Technology, Inc.
    FEI Number
    3005751028
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 15, 2016
    Terminated
    November 29, 2017
    Address
    10 Pomeroy Rd, Parsippany, NJ, 07054-3722

    Description

    TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB STR GRN SZ 5 17MM - 00588606517 TM MONO TIB STR GRN SZ 6 10MM - 00588606610 TM MONO TIB STR GRN SZ 6 12MM - 00588606612 TM MONO TIB STR GRN SZ 6 14MM - 00588606614 TM MONO TIB STR GRN SZ 6 17MM - 00588606617 TM MONO TIB STR BLUE SZ 7 10MM - 00588606710 TM MONO TIB STR BLUE SZ 7 12MM - 00588606712 TM MONO TIB STR BLUE SZ 7 14MM - 00588606714 TM MONO TIB STR BLUE SZ 7 17MM - 00588606717 TM MONO TIB STR GRN SZ 5 10MM - 00588607510 TM MONO TIB STR GRN SZ 5 12MM - 00588607512 TM MONO TIB STR GRN SZ 5 14MM - 00588607514 TM MONO TIB STR GRN SZ 5 17MM - 00588607517

    Reason

    Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

    Action

    Zimmer issued an Urgent Medical Device Recall Letter dated 4/15/2016.

    Distribution

    Nationwide and Foreign.

    Quantity

    19,884 total