BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

    Recall: Z-1466-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1466-2023
    Event ID
    92078
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 3, 2023
    Initiation Date
    April 10, 2023
    Classification Date
    April 26, 2023
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation

    Reason

    Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.

    Code Info

    UDI/DI 00889797101011, Lot Number 1736809

    Distribution

    US Nationwide distribution.

    Quantity

    41 units