BEUDAMED
    FDA Enforcement Class II Terminated

    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.

    Recall: Z-2445-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2445-2015
    Event ID
    71461
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Omnilife Science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 2, 2015
    Initiation Date
    June 4, 2015
    Classification Date
    August 21, 2015
    Termination Date
    September 28, 2015
    Address
    50 Oconnell Way Ste 10, N/A, East Taunton, MA, 02718-1394, United States

    Description

    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.

    Reason

    The device may have improper screw hole placement due to inaccurate location of the index line.

    Code Info

    H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097

    Distribution

    US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.

    Quantity

    112