BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.

    Recall: Z-0261-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0261-2016
    Event ID
    72297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    September 8, 2015
    Classification Date
    November 10, 2015
    Termination Date
    July 25, 2017
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.

    Reason

    Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.

    Code Info

    Catalog Numbers 6260-5-028; 6260-5-032; 6260-5-132; 6260-5-232, 232; 6260-5-328; 6260-5-332; 6260-5-428; 6260-5-432; 6260-9-0928; 6260-9-032, 6260-9-132, 6260-9-232, 6260-9-328, 6260-9-332, 6260-9-428, 6280-0-128, 6280-0-228, 6280-0-232, 6280-0-332 exp- dates july 2019 to august 2019

    Distribution

    Nationwide Distribution

    Quantity

    201