BEUDAMED
    FDA Recall Terminated

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    Recall: Z-1247-2022 · Initiated April 13, 2022

    Recall

    Recall Number
    Z-1247-2022
    Event Number
    90074
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 13, 2022
    Terminated
    October 23, 2023
    Address
    3973 Delp St, Memphis, TN, 38118-6110

    Description

    GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1

    Reason

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

    Action

    The recalling firm emailed their sales agents on 4/13/2022 to notify them the implants were associated with a recall and must be returned immediately to the recalling firm. It also said that replacements are currently on order and will be overnighted to them once they are available. A copy of the Field Safety Notice from the manufacturer was forwarded to the sales agents. The Notice informed them the three affected lots have been assembled following an incorrect packing list, resulting in a size 2 trial baseplate being inserted in a size 1 instrument set, and that all the other devices included in the packing list and instrument set are correct.

    Distribution

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

    Quantity

    50 units