BEUDAMED
    FDA Enforcement Class II Terminated

    Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.

    Recall: Z-0786-2022 · Reported March 23, 2022

    Enforcement

    Recall Number
    Z-0786-2022
    Event ID
    89507
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 23, 2022
    Initiation Date
    February 15, 2022
    Classification Date
    March 15, 2022
    Termination Date
    October 5, 2022
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.

    Reason

    An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

    Code Info

    Lot #73967511638696

    Distribution

    International distribution to the country of France.

    Quantity

    1 package