BEUDAMED
    FDA Enforcement Class II Terminated

    WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220

    Recall: Z-1101-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1101-2020
    Event ID
    84673
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    December 27, 2019
    Classification Date
    February 6, 2020
    Termination Date
    July 23, 2021
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220

    Reason

    Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

    Code Info

    Lot Code 1633010

    Distribution

    US

    Quantity

    39 devices