BEUDAMED
    FDA Enforcement Class II Ongoing

    JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

    Recall: Z-1393-2023 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1393-2023
    Event ID
    91974
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 26, 2023
    Initiation Date
    March 27, 2023
    Classification Date
    April 14, 2023
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

    Reason

    A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

    Code Info

    Catalog Number: 74026178; UDI/DI: 00885556677209; Batch Number: 22CAP0038R; Lot Number: 22CAP0038R

    Distribution

    US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.

    Quantity

    12 units