BEUDAMED
    FDA Recall Terminated

    MAKOplasty Hip Array Kit Laminate 150230

    Recall: Z-1588-2016 · Initiated November 25, 2015

    Recall

    Recall Number
    Z-1588-2016
    Event Number
    73199
    Firm
    Mako Surgical Corporation
    FEI Number
    3005985723
    Product Code
    OLO
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 25, 2015
    Terminated
    August 25, 2016
    Address
    2555 Davie Rd, Ste 110, Plantation, FL, 33317-7424

    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.

    Action

    On 12/09/2015, Product Field Action Letters and Product Accountability forms were sent to Branch/Agencies via overnight courier with a return receipt; Hospital Risk Management were sent Notification letters and a Product Recall Acknowledgement form with return receipt on 12/9;/2015.

    Distribution

    CO, KY, MN, WA and WV

    Quantity

    10 units.