BEUDAMED
    FDA Enforcement Class II Terminated

    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

    Recall: Z-2241-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2241-2014
    Event ID
    68527
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Omnilife Science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    May 9, 2014
    Classification Date
    August 15, 2014
    Termination Date
    August 19, 2014
    Address
    50 Oconnell Way Ste 10, East Taunton, MA, 02718-1394, United States

    Description

    Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA

    Reason

    Staining on hip implant.

    Code Info

    Lot: 17284

    Distribution

    US: CA, OK, VA, FL, MA, NY, TX

    Quantity

    13 devices