BEUDAMED
    FDA Enforcement Class II Terminated

    2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)

    Recall: Z-1824-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1824-2019
    Event ID
    82738
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2019
    Initiation Date
    April 25, 2019
    Classification Date
    June 15, 2019
    Termination Date
    April 22, 2021
    Address
    2555 Davie Rd Ste 110, N/A, Davie, FL, 33317-7424, United States

    Description

    2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)

    Reason

    The bearings of the saw attachments were ungreased.

    Code Info

    Catalog Number: 212186 Lot Number: 35051018 and 35050918 UDI: (01)00848486032111(10)35051018 and (01)00848486032111(10)35050918

    Distribution

    AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands

    Quantity

    7