BEUDAMED
    FDA Recall Terminated

    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 00725505432 ACET CUP, 0 DEG, 32MM X 54MM 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 00726007032 ACET CUP, 10 DEG, 32MM X 70MM

    Recall: Z-1955-2016 · Initiated April 15, 2016

    Recall

    Recall Number
    Z-1955-2016
    Event Number
    73536
    Firm
    Zimmer Trabecular Metal Technology, Inc.
    FEI Number
    3005751028
    Product Code
    LPH
    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

    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACETAB.CUPW/SH,0DEG,28MMX58MM 00720506028 ACETAB.CUPW/SH,0DEG,28MMX60MM 00720506228 ACETAB.CUPW/SH,0DEG,28MMX62MM 00720506428 ACETAB.CUPW/SH,0DEG,28MMX64MM 00721004222 ACETAB.CUPW/SH,10DEG,22MMX42MM 00721004422 ACETAB.CUPW/SH,10DEG,22MMX44MM 00721005028 ACETAB.CUPW/SH,10DEG,28MMX50MM 00721005228 ACETAB.CUPW/SH,10DEG,28MMX52MM 00721005628 ACETAB.CUPW/SH,10DEG,28MMX56MM 00721006428 ACETAB.CUPW/SH,10DEG,28MMX64MM 00721006628 ACETAB.CUPW/SH,10DEG,28MMX66MM 00721006828 ACETAB.CUPW/SH,10DEG,28MMX68MM 00721007028 ACETAB.CUPW/SH,10DEG,28MMX70MM 00725504222 ACETAB.CUP, 0 DEG, 22MM X 42MM 00725504622 ACETAB.CUP, 0 DEG, 22MM X 46MM 00725504626 ACETAB.CUP, 0 DEG, 26MM X 46MM 00725504828 ACETAB.CUP, 0 DEG, 28MM X 48MM 00725505232 ACETAB.CUP, 0 DEG, 32MM X 52MM 00725505432 ACET CUP, 0 DEG, 32MM X 54MM 00725505632 ACET CUP, 0 DEG, 32MM X 56MM 00725505828 ACETAB.CUP, 0 DEG, 28MM X 58MM 00725505832 ACET CUP, 0 DEG, 32MM X 58MM 00725506028 ACETAB.CUP, 0 DEG, 28MM X 60MM 00725506032 ACET CUP, 0 DEG, 32MM X 60MM 00725506228 ACETAB.CUP, 0 DEG, 28MM X 62MM 00725506232 ACET CUP, 0 DEG, 32MM X 62MM 00725506428 ACETAB.CUP, 0 DEG, 28MM X 64MM 00725506432 ACET CUP, 0 DEG, 32MM X 64MM 00725506628 ACETAB.CUP, 0 DEG, 28MM X 66MM 00725506632 ACET CUP, 0 DEG, 32MM X 66MM 00725506828 ACETAB.CUP, 0 DEG, 28MM X 68MM 00725506832 ACET CUP, 0 DEG, 32MM X 68MM 00725507028 ACETAB.CUP, 0 DEG, 28MM X 70MM 00725507032 ACET CUP, 0 DEG, 32MM X 70MM 00726004222 ACETAB.CUP,10 DEG, 22MM X 42MM 00726004828 ACETAB.CUP,10 DEG, 28MM X 48MM 00726005028 ACETAB.CUP,10 DEG, 28MM X 50MM 00726005228 ACETAB.CUP,10 DEG, 28MM X 52MM 00726005232 ACETAB.CUP,10 DEG, 32MM X 52MM 00726005432 ACET CUP, 10 DEG, 32MM X 54MM 00726005632 ACET CUP, 10 DEG, 32MM X 56MM 00726005832 ACET CUP, 10 DEG, 32MM X 58MM 00726006032 ACET CUP, 10 DEG, 32MM X 60MM 00726006428 ACETAB.CUP,10 DEG, 28MM X 64MM 00726006432 ACET CUP, 10 DEG, 32MM X 64MM 00726006628 ACETAB.CUP,10 DEG, 28MM X 66MM 00726006632 ACET CUP, 10 DEG, 32MM X 66MM 00726006828 ACETAB.CUP,10 DEG, 28MM X 68MM 00726006832 ACET CUP, 10 DEG, 32MM X 68MM 00726007028 ACETAB.CUP,10 DEG, 28MM X 70MM 00726007032 ACET CUP, 10 DEG, 32MM X 70MM

    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