BEUDAMED
    FDA Enforcement Class II Terminated

    Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

    Recall: Z-2745-2020 · Reported August 12, 2020

    Enforcement

    Recall Number
    Z-2745-2020
    Event ID
    86048
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mako Surgical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 12, 2020
    Initiation Date
    July 9, 2020
    Classification Date
    July 31, 2020
    Termination Date
    June 16, 2023
    Address
    2555 Davie Rd Ste 110, Davie, FL, 33317-7424, United States

    Description

    Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

    Reason

    Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

    Code Info

    UDI: (01)00848486022167(21)1905386; (01)00848486022167(21)1905389; (01)00848486022167(21)1905359; (01)00848486022167(21)1905352; (01)00848486022167(21)1905369; (01)00848486022167(21)1905387; (01)00848486022167(21)1905383; (01)00848486022167(21)1905353; (01)00848486022167(21)1905356; (01)00848486022167(21)1905357; (01)00848486022167(21)1905365; (01)00848486022167(21)1905388;

    Distribution

    TX, MN, CA, RI, FL, NY, AZ, TN

    Quantity

    12 units