BEUDAMED
    FDA Recall Terminated

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    Recall: Z-2661-2017 · Initiated May 19, 2017

    Recall

    Recall Number
    Z-2661-2017
    Event Number
    77467
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    KRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 19, 2017
    Posted
    June 12, 2017
    Terminated
    May 29, 2018
    Address
    3973 Delp St, Memphis, TN, 38118-6110

    Description

    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO

    Reason

    One lot of product does not include a screw for attachment to the tibial base plate.

    Action

    On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone.

    Distribution

    CA, AZ, NC, Israel, France

    Quantity

    4 units