BEUDAMED
    FDA Enforcement Class II Terminated

    Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

    Recall: Z-1694-2021 · Reported June 9, 2021

    Enforcement

    Recall Number
    Z-1694-2021
    Event ID
    87862
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Signature Orthopedics Pty Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 9, 2021
    Initiation Date
    April 20, 2021
    Classification Date
    May 28, 2021
    Termination Date
    January 19, 2023
    Address
    Lane Cove W, 7 Sirius Rd, Lane Cove West, N/A, Australia

    Description

    Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.

    Reason

    Product mislabeled, with the incorrect product inside the package.

    Code Info

    LOT# 71541-1

    Distribution

    US Nationwide distribution in the state of NC.

    Quantity

    3 units