BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.

    Recall: Z-1567-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1567-2022
    Event ID
    90660
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 31, 2022
    Initiation Date
    July 27, 2022
    Classification Date
    August 23, 2022
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423, United States

    Description

    Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.

    Reason

    An incorrect sizing label was applied to the carton packaging.

    Code Info

    Lot numbers 1728375 and 1728376, UDI #00840420121707.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AZ, CA, FL, GA, NY, PA, and TN. The countries of the Australia, France, the Netherlands, Sweden, and the United Kingdom.

    Quantity

    17 devices