BEUDAMED
    FDA Enforcement Class II Ongoing

    Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

    Recall: Z-0401-2022 · Reported December 29, 2021

    Enforcement

    Recall Number
    Z-0401-2022
    Event ID
    89086
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 29, 2021
    Initiation Date
    December 3, 2021
    Classification Date
    December 20, 2021
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System.

    Reason

    Incorrect product is contained in the packaging.

    Code Info

    Lot numbers 02010697711582590 and 02010697711582591, GTIN 00840420108340.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, IA, and SC. The countries of Australia, Canada, Chile, Spain, and United Kingdom.

    Quantity

    22 units