BEUDAMED
    FDA Enforcement Class II Terminated

    MAKOplasty Hip Array Kit Laminate 150230

    Recall: Z-1588-2016 · Reported May 11, 2016

    Enforcement

    Recall Number
    Z-1588-2016
    Event ID
    73199
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 11, 2016
    Initiation Date
    November 25, 2015
    Classification Date
    April 29, 2016
    Termination Date
    August 25, 2016
    Address
    2555 Davie Rd Ste 110, Plantation, FL, 33317-7424, United States

    Description

    MAKOplasty Hip Array Kit Laminate 150230

    Reason

    Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

    Code Info

    Catalog No. 210540, Lot Code: 150324

    Distribution

    CO, KY, MN, WA and WV

    Quantity

    10 units.