BEUDAMED
    FDA Enforcement Class II Terminated

    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

    Recall: Z-1683-2016 · Reported May 25, 2016

    Enforcement

    Recall Number
    Z-1683-2016
    Event ID
    73981
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Manufacturing B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 25, 2016
    Initiation Date
    May 4, 2016
    Classification Date
    May 16, 2016
    Termination Date
    July 5, 2017
    Address
    Turpeaux Industrial Park Rd 1 km 123.4, N/A, Mercedita, PR, 00715, United States

    Description

    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

    Reason

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

    Code Info

    LOTS: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436

    Distribution

    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.

    Quantity

    1199