BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1393-2023 · Initiated March 27, 2023

    Recall

    Recall Number
    Z-1393-2023
    Event Number
    91974
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    HSX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 27, 2023
    Posted
    April 14, 2023
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    Smith & Nephew notified consignees via email and overnight mail on 03/27/2023. Consignees were instructed to immediately review inventory and quarantine any affected units, notify customers if the product was further distributed, complete and return the response form and arrange for the return of affected units.

    Distribution

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

    Quantity

    12 units