BEUDAMED
    FDA Recall 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 · Initiated June 4, 2015

    Recall

    Recall Number
    Z-2445-2015
    Event Number
    71461
    Firm
    Omnilife Science Inc.
    FEI Number
    3008342029
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 4, 2015
    Posted
    August 21, 2015
    Terminated
    September 28, 2015
    Address
    50 Oconnell Way, Ste 10, East Taunton, MA, 02718-1394

    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.

    Action

    Omni sent an Urgent Medical Device Field Correction letter dated June 4, 2015 via email to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory for affected product and complete and return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.

    Distribution

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

    Quantity

    112