BEUDAMED
    FDA Enforcement Class II Terminated

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    Recall: Z-1247-2022 · Reported June 15, 2022

    Enforcement

    Recall Number
    Z-1247-2022
    Event ID
    90074
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 15, 2022
    Initiation Date
    April 13, 2022
    Classification Date
    June 7, 2022
    Termination Date
    October 23, 2023
    Address
    3973 Delp St, Memphis, TN, 38118-6110, United States

    Description

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    Reason

    A Size 2 trial baseplate was assembled with Size 1 instrument sets.

    Code Info

    Model Number/Reference Code: 11.01041; UDI-DI: 07630971252509; Lot Numbers Lots: 2109258 (exp. 06/24/2026), 2111198 (exp. 10/04/2026), 2115530 (exp. 10/27/2026)

    Distribution

    Distribution was made to AK, CA, CT, IN, MA, NJ, and PA. There was no foreign/military/government distribution.

    Quantity

    50 units