BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm

    Recall: Z-0650-2016 · Reported January 20, 2016

    Enforcement

    Recall Number
    Z-0650-2016
    Event ID
    72521
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 20, 2016
    Initiation Date
    November 17, 2015
    Classification Date
    January 13, 2016
    Termination Date
    July 5, 2016
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm

    Reason

    PMMA is listed as a material on the label but the product does not contain PMMA.

    Code Info

    Part #11-162709 9mm Lots: 329750, 404380, 487400, 767120, 951680 Part # 11-162711 11mm Lots: 329760, 505030, 505050 Part # 11-162713 13mm Lots: 837750, 977460 Part # 11-162715 15mm 772410, 837780, 897070, 951810 Part # 11-162717 17mm Lots: 311410, 410500, 535530, 712800, 728080, 829580

    Distribution

    Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS

    Quantity

    21