BEUDAMED
    FDA Recall Open, Classified

    JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis

    Recall: Z-0157-2024 · Initiated September 27, 2023

    Recall

    Recall Number
    Z-0157-2024
    Event Number
    93156
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Component change control
    Initiated
    September 27, 2023
    Posted
    October 24, 2023
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis

    Reason

    The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

    Action

    Smith & Nephew, Inc. issued an Urgent Medical Device Recall Notice to its consignees on 09/27/2023 via email and overnight mail. The notice explain the issue, potential risk, and requested the following actions: Inspect inventory, locate, and quarantine the affected devices. Sales representatives, district offices, or distributors were directed to notify their customers The firm is seeking return of unused products.

    Distribution

    Worldwide distribution - US Nationwide and the country of Japan.

    Quantity

    28 units