BEUDAMED
    FDA Enforcement Class II Terminated

    SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613

    Recall: Z-0730-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0730-2019
    Event ID
    81917
    Classification
    Class II
    Status
    Terminated
    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
    January 23, 2019
    Initiation Date
    January 7, 2019
    Classification Date
    January 11, 2019
    Termination Date
    September 17, 2020
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    Description

    SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613

    Reason

    The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

    Code Info

    Lot Numbers: C63165, C63306, C63495

    Distribution

    NY, TN, Germany, Italy, Great Britain, Singapore

    Quantity

    72 units